During this meeting, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the new drug application (NDA) 22-472.
During this meeting, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), manufactured by MannKind Corporation.
Afrezza is a drug-device combination inhaler consisting of Afrezza Inhalation Powder single use dose cartridges. Afrezza is an ultra rapid-acting mealtime insulin therapy intended for glycemic control in adult patients with type 1 or type 2 diabetes mellitus.
In this meeting, there were 5 discussion questions and 2 voting questions. The vote regarding whether Afrezza should be approved for the more common, type 2 diabetes, resulted in a unanimous 14 to 0 in favor of approval. Regarding whether the drug should be approved for type 1 diabetes, 13 voted yes in support of approval while 1 voted against approval.
In the main trial for Type 1 diabetes patients, Afrezza was less effective than injected insulin in reducing blood sugar. Nonetheless, Afrezza still met the statistical criterion for success in the trial.
In the clinical trial for patients with Type 2 diabetes, the agency noted that Afrezza was better than an inhaled placebo, but the effect was “modest” compared with what was seen in the trials of many other diabetes drugs.
Dr. Robert J. Smith, an endocrinologist at the Alpert Medical School at Brown University and the committee’s acting chairman, commented on Afrezza after the vote, “As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin.”
In previous years, MannKind had failed to gain FDA approval, requiring the company to perform new clinical trials in order to get another shot at approval. If approved this time around, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the U.S.
The agency is not obligated to follow its committee’s recommendation, 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 AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com
Do you want a more detailed analysis of this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a detailed post-meeting outcome report!
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