Valeant made an unusual appearance in front of an FDA expert panel on Tuesday, and came out with a clear endorsement for an FDA approval of their psoriasis drug brodalumab.
The panel voted 18 to 0 in favor of approving brodalumab, despite the agency’s internal review, which linked the drug to 6 suicides and suicidal ideation as well as cardio risks. Four of the panelists recommended an approval with nothing more than a clear label warning on the risks involved, 14 voted yes on an approval with a risk management plan in place.
Some of the panel members recommended a black box warning, which could limit the drug’s commercial potential.
The panel, though, was won over by the efficacy data, the opportunity of adding a new weapon to be used against psoriasis and a willingness to find a way to manage what most considered a marginal risk of suicide. Most of the panelists dismissed any connection with MACE or cardio concerns.
“It seems to me the benefit for this drug has tremendous potential for these patients who are absolutely miserable,” says Harvard’s Lynn Drake, who sits on the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. “I think we have a drug here that is at some levels a bit of a game changer.” As for the six suicides: “It’s a suggestion, not a signal.”
Valeant, known for its aversion to R&D risk, bought the psoriasis drug brodalumab from AstraZeneca for the bargain basement rate of $100 million up front, $170 million in prelaunch milestones and another $175 million in sales bonuses. The big pharma unloaded the drug after its partner Amgen bailed out earlier after a close look at a link between the drug and suicides and suicidal thinking convinced them that the commercial opportunity had been upended.
Where Amgen saw failure Valeant smelled opportunity, bagging the drug ahead of the regulatory review. The company has made a practice of buying controversial or marginal drugs, like Provenge and brodalumab. But in recent months its business model, which depends heavily on ever-higher prices for portfolio drugs, has wilted under a bright spotlight of unfavorable attention, which has wilted its share price.
The FDA usually follow the guidance of its experts, but there’s no guarantee the agency will approve the drug as-is before first requiring a safety study. That’s the big risk that still remains, though the odds in Valeant’s favor clearly just improved by a wide margin.
Even if Valeant does overcome the safety issues and wins a formal approval, it will face off against a crowded field of rivals: Eli Lilly’s ixekizumab, approved in March as Taltz, Merck’s MK-3222 and J&J’s IL-23 inhibitor guselkumab. Novartis’ was first out into the market, with Cosentyx.
Get Endpoints News in your inbox
Newsletters for those who discover, develop, and market drugs. Join 13,000+ biopharma pros who read Endpoints News every day. Free subscription.
Subscribe to Endpoints
John Carroll, Editor and Co-Founder
We produce two daily newsletters designed to give you a complete picture of what's important in biopharma.