Valeant ($VRX) has been touting the potential of psoriasis candidate brodalumab to help the struggling company stage its turnaround. But ahead of an advisory committee meeting to assess the drug, FDA staffers aren’t quite sure how they feel.
A potential risk of suicide associated with the experimental med is challenging to assess because of limited data, the company said Friday in briefing documents, noting that “we cannot conclude whether or not suicide is a drug-related risk."
And while label warnings and a Risk Evaluation and Mitigation Strategies (REMS) program could come into play, “no risk management strategy will completely eliminate the risk.”
Brodalumab’s suicide link is what landed the med in Valeant’s hands in the first place. Last May, the 6 suicides that cropped up in clinical trials prompted Amgen ($AMGN) to bail on its long-running brodalumab collaboration with AstraZeneca ($AZN), and the British pharma giant sold rights to Valeant a few months later.
Now, it'll be up to the expert panel to decide to vote on whether the product is fit for FDA approval, and, if so, what precautionary measures should be implemented. The agency generally follows the recommendations of its advisers, though it isn't required to.
Valeant, though, is crossing its fingers hard for a positive vote. Its brodalumab pact, inked last September, joined a string of questionable transactions for the serial dealmaker, which had previously nabbed Provenge, the laggard cancer vaccine that bankrupted Seattle biotech Dendreon, and Sprout, maker of highly controversial female libido pill Addyi. Now, though, with shares under pressure from debt-default worries and pricing investigations--and products like Addyi not coming through for the drugmaker in the sales department--a brodalumab approval is even more critical to Valeant’s top line success.
The way Evercore ISI analyst Umer Raffat sees it, Valeant will get its wish. Although “there appears to be disagreement within the FDA” with different divisions reaching different conclusions regarding the suicide risk, he thinks the agency “is leaning toward approval.”
Even if brodalumab does nab a green light, though, Valeant will face some significant marketing hurdles. The FDA could slap the product with a black-box warning--the agency's most serious--in light of the fact that dermatologists prescribing the med “are not too familiar with recognizing suicidal ideation behavior,” Raffat wrote. “We suspect the FDA may side with the more conservative route."
And regulators are also debating a “more onerous step” on top of REMS, he noted. If they pin an Elements To Assure Safe Use (ETASU) program on the drug--which requires doctors to receive training and pharmacies to receive certification before prescribing and dispensing the drug--“commercial opportunity will be minimal.”
Plus, there’s the fact that brodalumab will have to contend with a couple other next-gen psoriasis treatments--and even more competition coming up the pipeline. Novartis’ ($NVS) Cosentyx has been snapping up market share since winning approval last year, and Eli Lilly’s ($LLY) Taltz recently joined the party. Other Big Pharma players, including Johnson & Johnson ($JNJ) and Merck ($MRK), are currently ushering their own prospects through the clinic.
- see the briefing documents (PDF)
Valeant adds Orexigen obesity med to products it's snapped up for no good reason
Valeant bets the odds on AZ's psoriasis med in $100M-plus development deal
Can AZ salvage brodalumab against next-gen psoriasis field?
Suicide stunner prompts Amgen to dump brodalumab, denting AstraZeneca's rep