FDA panel gives cautious nod to Valeant psoriasis drug, despite suicide concerns


An FDA advisory committee recommended that the agency approve Valeant’s brodalumab to treat moderate-to-severe plaque psoriasis. But it also advised that the biopharma implement additional risk-management options for suicidal ideation--which had proved to be a problem in Phase III testing.

Next up, brodalumab, a monoclonal antibody that targets the IL-17 receptor, has a Nov. 16 PDUFA date. It was accepted by the EMA for review during the fourth quarter.

The psoriasis drug had been under development by partners AstraZeneca ($AZN) and Amgen ($AMGN). But last May, Amgen left the collaboration after suicidal thoughts emerged as a problem in Phase III trial results. In August, Valeant ($VRX) stepped in to partner on brodalumab with AstraZeneca. Now, the former holds global marketing rights, except in Japan and some other Asian countries, where rights are held by Kyowa Hakko Kirin, and in Europe, where Leo Pharma holds rights.

At least a couple of the panel members suggested a black-box warning, according to an analyst note from Evercore ISI. While all the 18 committee members voted in favor of an FDA approval, 14 out of the 18 also voted that additional risk-management options for suicidal ideation should be implemented.

“The way FDA worded this voting question, it basically retained a lot of discretion on black box warning as well as what the REMS would look like,” summed up the Evercore ISI note from Umer Raffat.

The company remained upbeat, noting that the committee voted in favor of approval “with conditions related to product labeling and postmarketing/risk management obligations.” Several committee members cited the 6 suicides that were part of the data they reviewed.

The FDA reviewed data from three Phase III pivotal trials that showed brodalumab was effective in total skin clearance of psoriasis as compared with placebo--as well as superior to Stelara (ustekinumab), which is marketed by Johnson & Johnson’s ($JNJ) Janssen Biotech.

"Brodalumab is an extraordinary drug that has meaningfully improved the quality of life of some of my most difficult-to-treat psoriasis patients, many of whom achieved complete skin clearance with this treatment," said Dr. Mark Lebwohl, chairman of the Department of Dermatology at Mount Sinai School of Medicine, in a statement. He was a lead investigator in Phase III testing.

He concluded, "The Advisory Committee has recommended that this life-changing treatment should be available to psoriasis patients who require a treatment with brodalumab's unique mechanism of action.”

- here is the Valeant release

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