It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize this time of year. It seems like only yesterday the daffodils were waving in a nippy Spring breeze. Soon, the newly arrived grass will look thirsty and sad. But let’s not get ahead of ourselves.
Some things did move ahead this week though – certainly there was a lot of advisory committee action, so let’s take a look at it.
- Cholesterol Considerations – The Endocrinologic and Metabolic Drugs Advisory Committee met on June 9 and 10 this week and both days reviewed data for two investigative compounds seeking a cholesterol lowering indication. On June 9, the committee reviewed Praluent (alirocumab) Injection – a monoclonal antibody. The sponsors, Regeneron and Sanofi announced that the committee voted 13-3 that the cholesterol lowering benefit of the compound exceeded risks to the degree that supported approval. The safety and efficacy data included more than 5,000 patients from 10 pivotal phase 3 double blind trials. On the 10th, Amgen got its turn to discuss data on another biologic for the proposed indication of cholesterol treatment called Repatha (evolocumab). According to media coverage, the committee indicated approval with an 11-4 vote, but also got a recommendation for approval in treating a rare subset of familial hypercholesterolemia caused by genetic disease in a unanimous vote.
- Asthma Treatment Recommendation – The Pulmonary-Allergy Drugs Advisory Committee also met this week on June 11 to consider another biologic, mepolizumab – an IL-5 monoclonal antibody, this time proposed to treat asthma as an add-on maintenance treatment in patients 12 and older, submitted by GlaxoSmithKline. The company announced a unanimous vote in favor of recommending approval (14-0) for use in adults, but ultimately did not recommend approval for adolescents aged 12-17 with severe asthma, seeking further data. The company mentioned that the PDUFA date for the compound is November 4. While regulatory filings have been made outside the U.S., it is not yet approved in any country.
- FDA Issues Guidance on Drug Development for Duchenne – The agency is also announcing the availability of a draft guidance for drug development to treat Duchenne Muscular Dystrophy (DMD) – a form of muscular dystrophy that is caused by a genetic mutation that leads to muscle degeneration and resulting decreased life expectancy and a condition where treatments are needed. A docket has been opened for the submission of comments.
That’s all for me this week. Stay cool everyone!
