FDA Approves AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder for Asthma

In continuation of my update on (fluticasone propionate and salmeterol

   

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. AirDuo Digihaler is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

“We are thrilled to be able to expand our Digihaler™ portfolio to now include a maintenance treatment,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development at Teva Pharmaceuticals. “With this approval, patients can now track how frequently they are using their inhalers. Granting patients the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique.”

Like ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients four years and older, AirDuo® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow rates. This data is then sent to a companion mobile app using Bluetooth® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers. Patients can also schedule reminders on their smartphone to take their AirDuo® Digihaler™ as prescribed.

“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts,” said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. “The ability to now measure their inspiratory flow rates and track their maintenance medication use, as well as the frequency with which they use their inhaler, may provide important data and insights to help inform treatment discussions with physicians. As a doctor, it’s exciting that my patients are able to share this type of information with me.”

The approval of AirDuo Digihaler is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA. AirDuo Digihaler combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate, an inhaled corticosteroid (ICS) medicine that may help to decrease inflammation in the lungs, which can lead to breathing problems, and salmeterol, a long acting beta2 adrenergic agonist (LABA), which helps the muscles around the airways in the lungs stay relaxed in order to prevent symptoms. AirDuo Digihaler contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an ICS and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

AirDuo Digihaler was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. As a fixed dose combination asthma therapy containing an ICS and a LABA, AirDuo Digihaler contains the same active ingredients as Advair Diskus, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.

“For the 25 million Americans living with asthma1, advancements like this one are important and could help patients track their inhaler use and frequency,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “Allowing patients access to both their rescue and maintenance inhaler use information on their smartphones is a promising step towards potentially fostering greater discussions about asthma management.”

“The approval of AirDuo Digihaler is an important step for Teva and the respiratory community to create a technology platform for use in asthma management along with the previously-approved ProAir Digihaler,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “This technology aims at delivering innovations through cloud-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients.”

https://en.wikipedia.org/wiki/Fluticasone

https://en.wikipedia.org/wiki/Salmeterol

FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus

In continuation of my updates on fluticasone propionate & salmeterol

              

Mylan N.V. (NASDAQ: MYL)  announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus.

Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA earlier this month, which prompted an amendment to the label for certain inhaled corticosteroids, including Advair Diskus and any generic versions. Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.

Mylan CEO Heather Bresch commented, "Mylan remains steadfast in its efforts to expand patient access to medicines, and the FDA approval of Wixela Inhub reinforces our commitment to provide patients greater choice and lower-cost alternatives. This milestone represents the culmination of an extensive research and development program and Mylan's more than $700 million of investment. We're proud of our Wixela Inhub team, who worked tirelessly and in close collaboration with the FDA to bring this important medicine to market and add it to our growing global portfolio of more than 700 respiratory products. As one of the leading providers of prescription medicines in the U.S., we continue to execute on our mission and do our part to reduce costs for patients and identify pathways that help increase sustainability for the U.S. healthcare system overall."

Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.

Mylan President Rajiv Malik added, "We're pleased to offer the first FDA-approved generic of Advair Diskus, one of the leading treatments for asthma and COPD management today. We've long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. This complex product required a rigorous research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway. We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant. This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients."

The research and development program for Wixela Inhub compared all strengths of treatment to Advair Diskus in order to meet the FDA requirements of therapeutic equivalence for a substitutable generic. In the 28-day, randomized, double-blind, placebo-controlled, parallel group study of 1,128 adult asthma patients conducted to evaluate the local (lung) bioequivalence of Wixela Inhub 100 mcg/50 mcg and ADVAIR DISKUS 100 mcg/50 mcg, the two treatments produced equivalent efficacy. Both treatments were safe and well-tolerated with lower numbers of withdrawals due to asthma compared to the placebo group. The study included both naive and current users of Advair Diskus.

"Patients enrolled in clinical trials found Wixela Inhub easy-to-use and highly effective at controlling their asthma in a clinical bioequivalence study. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD.  We have waited for years for generic inhalers to emerge in respiratory medicine," said Edward Kerwin, MD of Crisor LLC, a division of the Clinical Research Institute located in Medford, Ore. and a Clinical Investigator on the Wixela Inhub clinical program.

Advair Diskus had U.S. sales of $4.2 billion for the 12 months ending November 30, 2018, according to IQVIA.

https://en.wikipedia.org/wiki/Salmeterol

https://www.drugbank.ca/drugs/DB00588

MEDA Announces Dymista Approved by the FDA

MEDA Announces Dymista Approved by the FDA:   The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, MP29-02 (tentatively called Dymista), a novel intranasal formulation of azelastine hydrochloride (above left structure)  and fluticasone propionate (right structure).  

The first study demonstrated that continuous treatment with MP29-02 for 1 year was well tolerated in patients with chronic allergic or non-allergic rhinitis, only 2.7% of patients treated with MP29-02 and 2.9% of patients treated with fluticasone propionate discontinued the study due to an adverse event. MP29-02 also provided sustained efficacy over the one-year study period. MP29-02-treated patients experienced consistently greater relief from their nasal symptoms than fluticasone treated patients over the course of the study. Statistically significant (P<.05) differences favoring MP29-02 over fluticasone were observed at months 1 through 7 and at months 9 and 11. 

The second and third studies in patients with seasonal allergic rhinitis (SAR) provided evidence that MP29-02 demonstrated significantly more effective relief of nasal symptoms (P<.05 vs. azelastine, fluticasone, and placebo) and significantly greater ocular benefits compared to placebo (P<.05) over a 2-week study period. The new data was the subject of platform presentations on Sunday, March 4, 2012 at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in Orlando, Florida. MP29-02 is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of SAR.

Ref : http://mb.cision.com/Main/357/9255877/10183.pdf

High-dose fluticasone effective against eosinophilic esophagitis, study shows...

I continuation of y update on Fluticasone..

Results from a clinical trial show that high doses of the corticosteroid fluticasone propionate safely and effectively induce remission in many people with eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus characterized by high levels of white blood cells called eosinophils. However, some trial participants did not respond to fluticasone even after six months of high-dose treatments, providing evidence that certain people with EoE are steroid-resistant. By analyzing gene expression -- the degree to which certain genes are turned on or off -- in esophageal tissues, the scientists identified a cluster of genes that may help predict steroid responsiveness.

Ref :Read more

High-dose fluticasone effective against eosinophilic esophagitis, study shows