Yesterday, a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) recommended approval of a new once-daily.
Yesterday, a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) recommended approval of a new once-daily, long-acting beta-agonist combination therapy for asthma, fluticasone furoate and vilanterol (FF/VI) inhalation powder, (Breo Ellipta, GlaxoSmithKline/Theravance) for use in adults, but not in children. The materials for this meeting can be found HERE.
Overall, the joint committees voted 16 to 4 that FF/VI — in a 100 microgram (mcg) or 200 mcg dose of fluticasone combined with 25 mcg of vilanterol should be approved for adults aged over 18 years. However, only two panel members voted in favor of approval for use in children aged one to 17 years, and 18 votes were against approval. The panel also voted 17 to 3 that the drug was safe for adults, but 1 to 18 that it was safe in children. Vilanterol belongs to a class of compounds called long-acting beta-adrenoceptor agonists (LABA) that have historically been linked to asthma-related deaths.
A majority (18 to 2) voted that FF/VI had efficacy in adults aged over 18 years, which was shown by an improvement in lung function and a decrease in exacerbation rates; which ultimately is expected to reduce the number of physician visits and prescriptions for corticosteroids. Panel chairman, Erik Swenson, MD, professor in the division of pulmonary and critical care medicine at the VA Puget Sound Health Care System in Seattle, Washington stated,“I don’t think that’s non-trivial, avoiding some doses of oral steroids.”
Asthma is a chronic lung disease that inflames and narrows the airways and affects approximately 26 million people in the USA. Despite medical advances, more than half of asthma patients continue to experience poor control and significant symptoms.
Breo Ellipta (FF/VI 100/25 mcg) was licensed by the US Food and Drug Administration under the brand name Breo Ellipta in May 2013 as a prescription medication for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Breo Ellipta is not currently indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
The FDA is not obligated to follow the advice of its advisory committee panels, but normally does so.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us