Members of an FDA-assembled panel of experts definitely agreed on one thing Tuesday: The benefits of Valeant Pharmaceuticals' psoriasis treatment brodalumab outweigh its risks. But how to manage those risks? That's where things got tricky.
The 18 advisory committee members unanimously backed the med for approval, despite 6 suicides that cropped up in clinical trials. But even if the FDA follows the panel's advice, launching brodalumab won’t necessarily be smooth sailing for the struggling company. Fourteen of 18 panelists voted for risk-management restrictions, and they “seemed to be leaning toward” a black-box warning--the FDA’s most serious--and a Risk Evaluation and Mitigation Strategies (REMS) program, Evercore ISI analyst Umer Raffat wrote in a Tuesday note to clients.
Safety restrictions and warnings could hobble brodalumab if it enters the race for psoriasis market share. Still, it’s good news for Valeant, which licensed the drug from AstraZeneca last year. The drugmaker is counting on brodalumab to make a serious impact on its battered top line; it’s taken a hit--particularly in its dermatology unit--since severing ties with specialty pharmacy Philidor, which a short-seller last year claimed the Canadian drugmaker was using to inflate sales.
How many patients the med actually reaches will depend on any risk-management measure's level of severity. They could hurt brodalumab’s chances of coming up big in the face of hefty competition--including Novartis’ Cosentyx, a fellow biologic that has been cruising since it scored its first approval last year. The Swiss giant’s product has since racked up two indications beyond psoriasis in an effort to get out in front of brodalumab and other competing prospects coming up Big Pharma pipelines.
In one scenario, for example, brodalumab could wind up with an Elements To Assure Safe Use (ETASU) program, which requires doctors to be trained and pharmacies to be certified before prescribing and dispensing the drug.
Of course, Valeant and industry watchers will just have to wait and see on that front, as what happens with the warning and REMS is the “FDA’s call,” Raffat wrote. The agency has “retained a lot of discretion” on the black box as well as “what the REMS would look like,” he said.
Now, it’ll be up to the FDA to hand down its final decision on brodalumab, which is due by Nov. 16. While the FDA isn’t required to follow the recommendations of its panels, it generally does.
"Brodalumab has the potential to improve the lives of many patients suffering from this chronic, debilitating disease, and we greatly appreciated the opportunity to present our body of evidence to the panel," Valeant CEO Joseph Papa said in a statement. "We look forward to working collaboratively with the FDA as it continues its review process."
- read Valeant's release
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