Valeant's (VRX) Brodalumab BLA Up for Review in the U.S.
Valeant Pharmaceuticals International, Inc.’s VRX Biologic License Application (BLA) for brodalumab is up for review by an FDA panel. The FDA Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) is slated to meet on Jul 19 to review the application.
Note that the briefing documents that were released last week do not appear promising.
We remind investors that Amgen AMGN had submitted the first Investigational New Drug Application (IND) for brodalumab in 2008. Thereafter, the sponsorship of the program was granted to AstraZeneca AZN, which subsequently transferred the same to Valeant.
Valeant’s BLA contains 21 studies that were conducted by Amgen and four studies that were conducted by Amgen’s partner in Japan. The candidate met all primary endpoints across the three pivotal phase III studies.
The most common adverse events associated with brodalumab were nasopharyngitis, upper respiratory tract infection, arthralgia and headache. However, events of suicidal ideation and behavior, along with major cardiovascular events, constituted the greatest risks. These events are considered important potential risks and will be the focus of the advisory committee.
We note that Amgen’s decision to terminate the co-development deal with AstraZeneca was essentially due to events of suicidal ideation and behavior in the brodalumab program, which the former believed would likely lead to restrictive labeling by the FDA. The company believed that such labeling requirements would limit the eligible patient population for the product upon approval.
Suicidal ideation and behavior was identified as a potential risk in 2014, quite late in the brodalumab psoriasis development program, when most patients had already completed 52 weeks of study.
Hence, we believe that the FDA advisory committee will focus on this aspect while reviewing the BLA and the outcome may not be favorable. In fact, even if a positive recommendation is given, the labeling would be accompanied by precautions and warnings.
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