- Valeant Pharmaceuticals on Tuesday won the backing of a Food and Drug Administration advisory panel for approval of its psoriasis drug broadalumab, a welcome break for a company which remains under scrutiny for its drug pricing tactics and heavy debt burden.
- The advisory committee recommended the FDA approve brodalumab, but only with labeling which warns of an increased risk of suicide. Committee members also said Valeant should be required to develop a risk management program to mitigate those risks.
- If approved by the FDA, brodalumab would join a crowded market in plaque psoriasis. Both Novartis and Eli Lilly also have recently approved drugs for that indication, and blockbuster biologics such as AbbVie's Humira or Amgen's Enbrel are leading treatments for inflammatory conditions such as plaque psoriasis.
In a report released ahead of Tuesday's panel meeting, FDA staff raised concerns over the number of suicides observed during the development of brodalumab. Six people had completed suicide in clinical trials of the drug, four of which occurred in the three Phase 3 trials supporting Valeant's submission to the FDA for approval.
Panel members felt the benefits of brodalumab outweighed the potential risks, but recommended the drug carry a warning of suicide risks if approved. In their report, FDA staff had noted the safety implications of the observed suicides were difficult to assess given a lack of data. One of the suicides was also judged to be related to a possible accidental drug overdose.
Winning the backing of the panel on Tuesday was important for Valeant, which has struggled to regain its luster after months of bad news. While Valeant appears to have put its financial reporting in order, the company is still struggling with about $30 billion in debt and continued criticism of its drug pricing.
New chief executive Joseph Papa has made efforts to revamp the drugmaker's image, assembling a special committee on drug pricing and closing out a federal investigation into one of its prior acquisitions.
While support of advisory panels doesn't guarantee an approval, the FDA usually follows the committee's advice. A target action date is set for November 16.
But approval for brodalumab may not be a homerun.
Sales of Novartis' Cosentyx are quickly gaining steam, hitting $260 million in Q2 ($180 million of which were in the U.S.). Cosentyx won U.S. approval for plaque psoriasis in January 2015, and has since been okayed for use in ankylosing spondylitis and psoriatic arthritis. Eli Lilly's Taltz also got a green light for use in plaque psoriasis earlier this year.
Both Cosentyx and Taltz target a protein known as IL-17A, preventing that protein from binding to its receptor and thereby limiting inflammatory responses. Brodalumab targets the IL-17 pathway as well, but binds to the receptor itself to inhibit inflammatory signalling.
Valeant bet $100 million upfront on brodalumab last year, buying global rights from AstraZeneca, except in Japan and some Asian countries. But AstraZeneca recently broke off its agreement with Valeant in Europe, handing commercialization rights in that market to LEO Pharma instead.