New Products

Valeant gets an FDA OK for new psoriasis drug brodalumab — but there’s a big catch

The FDA has come through with an approval for Valeant’s psoriasis drug brodalumab. But they’ve hobbled it with a black box safety warning on suicidal ideation and a risk mitigation marketing program that will likely hobble its revenue in an intensely competitive market.

An FDA panel already flagged through the drug — to be sold as Siliq — with many of the experts clearly more interested in obtaining another arrow for their quiver rather than the potential safety issues, which they felt were manageable.

At one point both AstraZeneca $AZN and Amgen $AMGN thought they were on to a new blockbuster as they started Phase III on brodalumab. Then it became evident the drug spurred suicidal thoughts among patients – some of whom went on to kill themselves. Amgen walked away, and after blustering about seeing it through, AstraZeneca sold it to a bottom-feeding Valeant for a mere $100 million upfront, $170 million in development milestones and $175 million in sales bonuses.

Now Valeant will get to compete in a fast-changing market, facing off against a crowded field of rivals: Eli Lilly’s ixekizumab, approved last March as Taltz, tildrakizumab (MK-3222) held by Sun Pharma and J&J’s IL-23 inhibitor guselkumab, now under FDA review. Novartis’ was first out into the market, with Cosentyx.

A spokesperson for the company — which has been accused of gouging payers in the past — said the company is not discussing the drug’s price publicly, and couldn’t give a timeline for when a price might be released.

“Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment.”


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RAPS Regulatory Convergence 2017