Valeant Drug Should Be Approved With Risk Plan, FDA Advisers Say

  • 14 panel members vote for psoriasis drug, with monitoring
  • There were six suicides in clinical trials for the treatment

Valeant Pharmaceuticals International Inc. won the backing of a panel of U.S. regulatory advisers who supported approval of its experimental psoriasis treatment, on the condition that the company takes extra steps to help mitigate possible suicide risk associated with the drug.

Food and Drug Administration advisers voted Tuesday to recommend that the agency clear the drug, brodalumab, for sale with the risk-management plan and a label that warns it may be linked to a higher risk of suicide. Six suicides occurred in clinical trials of the treatment, though one may have been due to an accidental overdose, according to FDA staff reviewing the drug.

The staff had differing opinions about how closely the drug is linked to the suicides, particularly since patients with psoriasis are often more prone to anxiety, depression and suicidal behavior. Fourteen panel members voted in favor of approving the drug with a risk management plan and a drug label that warned of suicide risk, while four panelists voted that the drug could be sold with a warning on the label and no risk plan.

Valeant shares rose less than 1 percent to $23.64 at 3:35 p.m. in New York. The stock is down 90 percent over the last 12 months, after the company has cut its financial outlook, changed chief executive officers, and dealt with criticism and investigation of its business practices.

Not a Clear Link

Panel members generally agreed that the six suicides were more of a suggestion that brodalumab could be linked to such risks, rather than a sign that the link is clear. They also said patients should be given access to the drug because it appears to work well against the disease, which can cause raised, red and scaly skin.

“The benefit of the drug has the potential to be absolutely tremendous,” said Lynn Drake, a panel member and a lecturer in the Department of Dermatology at Harvard Medical School. “I think we have a drug here that, hopefully at some level, is a bit of a game changer.”

Valeant is seeking to sell brodalumab to patients with moderate-to-severe plaque psoriasis, the most common form of an ailment that affects about 7.5 million Americans, according to the American Academy of Dermatology.

Tena Brown, an Oklahoma woman who spoke during the public comment portion of the meeting, showed pictures of her body covered in raised red patches -- the most severe manifestation. She spoke about dealing with psoriasis in her ears, between her toes and even on her genitals, and the conditions she’s developed that are linked to the disease, including suffering a stroke.

Other Drugs

There are plaque psoriasis treatments already on the market that don’t have issues with suicidal behavior, including Novartis AG’s Cosentyx and Eli Lilly & Co.’s Taltz, which are similar to brodalumab. The blockbuster Humira from AbbVie Inc., with $14 billion in sales last year, and Amgen Inc.’s Enbrel also treat plaque psoriasis and don’t carry warnings of increased suicide risk.

Valeant has proposed a risk-mitigation plan that would inform health-care providers about the possible suicide risk and the need to counsel patients as well as consider a referral to a mental health professional. The plan also would seek to educate patients about the signs and symptoms of suicidal behavior.

Valeant’s psoriasis drug targets receptors in the body that respond to groups of proteins called IL-17. By stopping IL-17 from activating the receptor, brodalumab prevents the body from inducing an inflammatory response, according to Valeant.

Valeant paid $100 million to acquire the commercial rights to the drug from AstraZeneca Plc in September. Amgen Inc. had previously ended its brodalumab collaboration with AstraZeneca when it appeared the medication might require a warning on suicide risk, which likely would limit sales. The FDA is expected to decide whether to approve brodalumab for sale by Nov. 16.

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