Valeant's skin jab brodalumab has taken a big step towards US approval after regulatory advisors backed the drug for adult patients with moderate-to-severe plaque psoriasis.
The US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18 to 0 for the approval of brodalumab injection, but 14 said the drug should only be cleared with labelling information of the risk of suicide and a related risk management plan.
"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, according to Bloomberg, adding: "I think we have a drug here that, hopefully at some level, is a bit of a game changer".
"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, Department of Dermatology, Mount Sinai School of Medicine.
"I am very pleased that 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, and I look forward to prescribing this therapy to patients who are suffering from the devastating effects of moderate to severe plaque psoriasis."
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, the drug prevents the body from receiving signals that may lead to inflammation.
The marketing application for brodalumab is based on data from the AMAGINE clinical development programme, which showed that a significant proportion of psoriasis patients given the drug achieved at least 75-percent improvement in disease severity from baseline versus placebo.
The drug is also under review in Europe, where LEO Pharma currently holds rights.
In further good news for Valeant and partner Progenics, the FDA has approved Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
Valeant expects to commence sales of the drug in the US in the third quarter.