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Just Approved and Launched 

November 1, 2017

FDA-Approved Drug for Pediatric PAH

In September, the FDA approved Johnson & Johnson’s Tracleer (bosentan) in a 32-mg tablet "to treat pulmonary arterial hypertension in children ages three and older." J&J acquired the treatment in its acquisition of Actelion.

 

Just Approved and Launched

October 3, 2017 at 2:40 pm 

FDA Approval for New COPD Treatment

GlaxoSmithKline and Innoviva, Inc. announced that the U.S. Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.

 

Just Approved and Launched 

August 5, 2017 at 12:01 am 

FDA Approval of QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol
Teva announced that the U.S. Food and Drug Administration (FDA) has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA) inhalation aerosol for the maintenance treatment of asthma as a prophylactic therapy in patients four years of age and older. QVAR® RediHaler™ is not indicated for the relief of acute bronchospasm. It differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated MDI, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active drug ingredient found in QVAR®(beclomethasone dipropionate HFA) Inhalation Aerosol, with a different mode of delivery.

Tafinlar® and Mekinist® FDA Approved for Lung Cancers With BRAF Mutations
The U.S. Food and Drug Administration (FDA) recently approved the combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®)  ̶  both owned by Novartis  ̶  for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAV gene called the V600E mutation. Dabrafenib and trametinib block different growth-promoting signals in the MAPK pathway that are activated by the V600E BRAF mutation ̶  dabrafenib inhibits the BRAF protein, whereas trametinib is a MEK inhibitor. This is the first approval specifically for patients with BRAF V600E mutation-positive metastatic NSCLC.

FDA Approves KALYDECO® for Cystic Fibrosis With Certain Residual Function Mutations
Vertex Pharmaceuticals Incorporated recently announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This approval was based on Phase 3 clinical data for KALYDECO® in these mutations, and follows the FDA’s approval of KALYDECO in May 2017 for 23 other residual function mutations, which was based on analyses of in vitro data. Both approvals are supported by more than five years of real-world clinical experience that demonstrate KALYDECO’s established safety and efficacy profile.

 

Just Approved and Launched

May 1, 2017 at 4:18 pm 

Teva Launches AirDuo™ RespiClick® and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol

On April 20, Teva Pharmaceutical Industries Ltd., announced the simultaneous launch of AirDuo™ RespiClick® (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist (LABA) combination. The launch seeks to offer greater access to lower-cost asthma inhaler technology, and Teva expects that sales of the authorized generic will represent most of the sales of the two products. AirDuo™ RespiClick® was approved by the U.S. Food and Drug Administration (FDA) in January 2017 in three doses: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily.

New Maintenance COPD Treatment Option Now Available

On April 29, Sunovion Pharmaceuticals Inc., announced the launch of Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder, a combination bronchodilator approved in the U.S. for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The UTIBRON NEOHALER is not indicated to treat asthma or for the relief of sudden symptoms of COPD. An important feature of the NEOHALER device is that it offers several feedback mechanisms that allow patients to see whether or not the capsule is empty and provide dose confirmation. It is the latest product available in an important class of combination bronchodilators that are recommended as maintenance treatment for those suffering from COPD by the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report.

 

Just Approved and Launched

March 2, 2017 at 11:31 am 

FDA Expands Approval of SPIRIVA® RESPIMAT® Inhalation Spray for Maintenance Treatment of Asthma in Children

On Feb. 16, the U.S. Food and Drug Administration approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people aged six years and older. The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric exclusivity to SPIRIVA RESPIMAT in light of the clinical trials conducted by Boehringer Ingelheim. SPIRIVA RESPIMAT, which is delivered as two puffs once a day of 1.25 mcg per puff, is part of a class of medicines called long-acting muscarinic antagonist (LAMA), and is the only one of its kind approved for asthma. This FDA approval is based on efficacy and safety data from the Phase II and Phase III UniTinA-asthma® clinical development program, which included more than 150 sites globally with more than 6,000 patients, including 804 children (aged 6‒11 years).

 

Just Approved and Launched

December 16, 2016 at 1:02 pm 

GSK Files Regulatory Submission With EU for Once-Daily, Closed Triple Combination Therapy FF/UMEC/VI for Patients With COPD

On Dec. 2, GlaxoSmithKline and Innoviva, Inc. announced the filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement of the submission of a New Drug Application for FF/UMEC/VI in the United States in November 2016. The EU regulatory submission of closed triple therapy comprises a Marketing Authorisation Application for a maintenance treatment to relieve symptoms of adult patients with COPD. It is based on data from the closed triple combination therapy development programme including data from the phase III FULFIL study, as well as data from studies with FF, UMEC and VI either alone or in combination.

 

Just Approved and Launched

November 10, 2016 at 2:15 pm 

Oct. 18, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy.

Oct. 24, 2016 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, KEYTRUDA is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients.

 

Just Approved and Launched

September 12, 2016 at 4:52 pm 

EDWARDS INTUITY Elite Rapid Deployment Valve Receives FDA Approval

On Aug. 15, Edwards Lifesciences Corporation announced that the U.S. Food and Drug Administration approved the advanced EDWARDS INTUITY Elite valve system, a rapid deployment device that enables surgeons to streamline concomitant procedures.

FDA approval was supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 centers in the United States.

 

Just Approved and Launched

August 7, 2016 at 12:00 am 

FDA Approves Xolair® for Allergic Asthma in Pediatric Patients

On July 6, the FDA approved the supplemental Biologics License Application (sBLA) to extend the allergic asthma indication for Genentech’s Xolair® (omalizumab) to pediatric patients, ages six to 11 years. Xolair® — which has been used to treat more than 200,000 allergic asthma patients since its approval in 2003 for individuals 12 years and older — is now indicated for pediatric patients with severe to persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

Asthma is one of the most common long-term diseases in children, affecting approximately 6.3 million people under 18, or one in 12 children in the United States. The American Academy of Pediatrics estimates that between 70 and 80 percent of school-aged children with asthma also have allergies, which are among the most common triggers for asthma.

Learn more.

 

Just Approved and Launched

May 6, 2016 at 12:01 pm 

April 22, 2016 – Todd Austin, Executive Vice President, Global Marketing and Corporate Strategy at MGC Diagnostics®, has provided funding to establish the Dr. Robert Crapo Memorial Lifetime Achievement Award for Pulmonary Diagnostics.MGC Diagnostics and Medisoft are global medical technology companies dedicated to cardiorespiratory health solutions.  The Dr. Robert Crapo Memorial Lifetime Achievement award recognizes an established or senior investigator with recognized and distinguished scientific achievement in the field of pulmonary function testing or exercise physiology.  The first annual award will be presented at the ATS 2016 International Conference during the RSF Assembly Meeting.

April 25, 2016 – AstraZeneca announced that the US Food and Drug Administration has approved BEVESPI AEROSPHERE™ (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated to treat asthma or for the relief of acute bronchospasm.

Jerusalem, April 29, 2016 – Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). ProAir RespiClick® was approved by the FDA for use in patients 12 years of age and older in March 2015 and remains the only breath-activated, multi-dose, dry powder, short-acting beta-agonist (SABA) inhaler available in the U.S.

 

Just Approved and Launched

April 7, 2016 at 12:00 am 

Cambridge 16 March 2016 – PneumaCare Ltd (Cambridge, UK) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device. Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen. The technology can be used to accurately measure respiratory status in patients with a wide range of respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), pneumonia and lung failure, and to assess patients before and after surgery.

Jerusalem, March 23, 2016 – Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. CINQAIR® is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.

RIDGEFIELD, Conn., March 29, 2016 – Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved a sNDA for STIOLTO RESPIMAT that adds data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD) to the product labelling. These data, which are from the OTEMTO® 1&2 clinical studies, show a clinically meaningful improvement in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ), which is a disease-specific patient-reported instrument that evaluates symptoms, activities, and the impact of the disease on daily life.

 

Just Approved and Launched

February 10, 2016 at 8:30 pm 

The European Commission approved once-daily osimertinib tablets (Tagrisso, AstraZeneca) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) that is positive for the epidermal growth-factor receptor (EGFR) T790M mutation. Diagnostic testing is required to establish the presence of the mutation.

SPIRIVA® RESPIMAT® (tiotropium bromide) inhalation spray is now available in the U.S. for maintenance treatment of asthma. The drug can help the nearly 22 million American adults and adolescents living with asthma whose symptoms may have a negative impact on their ability to perform daily activities.

 

Just Approved and Launched

January 6, 2016 at 10:01 am 

The FDA recently approved Uptravi, developed by Actelion Pharmaceuticals. Uptravi is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

 

Just Approved and Launched

December 16, 2015 at 12:02 am 

Pradaxa® (dabigatran etexilate mesylate) developed by Boehringer Ingelheim Pharmaceuticals for prophylaxis of deep venous thrombosis and pulmonary embolism after hip replacement surgery received approval from the U.S. Food and Drug Administration.

 

Just Approved and Launched

November 25, 2015 at 12:01 am 

KALYDECO® (ivacaftor) developed by Vertex Pharmaceuticals for people with cystic fibrosis was approved by the European Union. Ivacaftor is the first medicine to treat the underlying cause of cystic fibrosis in people with specific mutations in the CFTR gene.

 

Just Approved and Launched

November 18, 2015 at 12:01 am 

The FDA recently approved the Utibron Neohaler (indacaterol/glycopyrrolate), manufactured by Novartis, for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

The FDA recently approved Nucala (mepolizumab) for the treatment of eosinophilic asthma, a form of severe asthma. Manufactured by GSK, the medicine is the first and only approved, biologic therapy specifically developed for people with severe asthma with eosinophilic inflammation.

FDA granted early approval to Tagrisso, also known as AZD9291 and developed by AstraZeneca, which is for a sub-set of lung cancer patients whose diseases worsened after other treatment therapies. The FDA approved a new mutation diagnostic test made by Roche, which Tagrisso is designed to target.

 

Just Approved and Launched: Iressa

July 15, 2015 at 12:01 am 

The U.S. Food and Drug Administration recently approved Iressa, manufactured by AstraZeneca, as a first-line treatment for patients with late-stage non-small cell lung cancer and a mutated epidermal growth factor receptor gene. Learn more.

 

Just Approved and Launched

July 8, 2015 at 12:03 am 

The FDA recently approved Stiolto Respimat Inhalation Spray, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., as a long-term, once-daily treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It was not approved for the treatment of asthma or acute deterioration of COPD.

 

Just Approved and Launched

June 1, 2015 at 12:03 am 

The U.S. Food and Drug Administration has recently approved Breo Ellipta for the once-daily treatment of asthma in patients older than 18. The drug was previously approved by the FDA to treat airflow obstruction and reduce exacerbations in patients with COPD.

The FDA also recently approved Avelox for the treatment of both pneumonic plague and septicemic plague. The drug also was approved for the prevention of plague in adults.

Inspire Medical Systems’ Upper Airway Stimulation, a sleep apnea device, has been approved by the Government Services Administration for use at U.S. military treatment facilities and Veteran Administration hospitals. The device was previously approved by the FDA for civilian use.

European Union health officials have approved Zykadia, which is manufactured by Novartis, for the treatment of advanced non-small cell lung cancer patients with a specific mutation of the anaplastic lymphoma kinase (ALK) protein. The drug was previously approved by the FDA in April 2014.

 

Just Approved and Launched

April 1, 2015 at 12:02 am 

The U.S. Food and Drug Administration recently approved Opdivo, also known as nivolumab, as a second-line treatment for squamous cell cancer, making it the first immune-based lung cancer treatment, according to the New York Times. The drug was originally approved in 2014 to treat advanced melanoma.

The U.S. Food and Drug Administration also recently approved Kalydeco for the treatment of pediatric cystic fibrosis in children ages 2-5 with some underlying gene mutations, according to the Boston Business Journal. The drug was previously approved by the FDA in 2012 for patients over the age of 6 with the gene mutations.

 

Just Approved and Launched

March 2, 2015 at 12:01 am 

SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray, which was approved in late 2014 by the U.S. Food and Drug Administration, is now available. Spiriva Respimat was approved for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients.

 

Just Approved and Launched

February 2, 2015 at 12:01 am 

GlaxoSmithKline plc announced in January the availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the U.S. Arnuity™ Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid medicine for the maintenance treatment of asthma. It is indicated for once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Incruse® Ellipta® (umeclidinium bromide), is an anticholinergic indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Vertex Pharmaceuticals Inc. received U.S. Food and Drug Administration approval in January for a supplemental new drug application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene. KALYDECO is now approved for use in the U.S. in people ages 6 and older with CF with one of the following ten mutations: R117H, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D.

 

Just Approved and Launched

December 1, 2014 at 12:04 am 

The U.S. Food and Drug Administration has approved Spiriva® Respimat® (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim Pharmaceuticals, Inc. anticipates SPIRIVA RESPIMAT to be available in January 2015.

 

Just Approved and Launched

November 3, 2014 at 12:02 am 

Two drugs were approved for the treatment of idiopathic pulmonary fibrosis by the U.S. Food and Drug Administration: Esbriet (pirfenidone) and Ofev (nintedanib). The Oct. 15 announcement follows separate clinical trials in which the decline in forced vital capacity was significantly reduced in patients who took either pirfenidone or nintedanib, respectively, compared to patients receiving placebo, the FDA notes. Esbriet is manufactured for InterMune, Inc., Brisbane, CA. Ofev is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.

The FDA has approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates SPIRIVA RESPIMAT to be available in January 2015.

 

Just Approved and Launched

September 2, 2014 at 12:00 am 

The FDA has approved a Supplemental New Drug Aplication for the Bristol-Myers Squibb and Pfizer prescription blood thinner Eliquis (apixaban) for the treatment of deep vein thrombosis and pulmonary embolism. Eliquis had been approved in March to reduce the risk of stroke and blood clots in people who have atrial fibrillation, and in June, the European Medicines Agency Committee for Medicinal Products for Human Use recommended the approval of its use for DVT and PE.

The FDA has accepted to review Boehringer Ingelheim’s New Drug Application for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

 

Just Approved and Launched

August 1, 2014 at 12:02 am 

ResMed, which manufactures and distributes medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders, has added the AirFit F10 compact full face mask and AirFit N10 compact nasal mask to its AirFit™ line. The circular diffused venting of the AirFit F10 “directs exhaled air more evenly and makes it less likely to rebound off surrounding objects or bed partners, creating a more peaceful sleeping environment.” The AirFit N10 weighs less than 3 ounces and has an under-eye frame that provides a clear line of sight.

Teva Pharmaceutical Industries Ltd. Has received U.S. Food and Drug Administration approval for QVAR® (beclomethasonedipropionate HFA) with a dose counter for the ongoing treatment of asthma as a preventative therapy in patients five years of age and older. The dose counter is designed to help asthma patients, as well as their caregivers, keep track of the number of doses remaining in the canister. The new product will be commercially available later this year.