Valeant announced that the Food and Drug Administration (FDA)’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18-0 for the approval of brodalumab injection to treat adults with moderate-to-severe plaque psoriasis with conditions related to product labeling and post-marketing/risk management obligations. Specifically, the panel addressed the risk of suicidal ideation and behavior (SIB) which was reported during the trials, however no definitive conclusions on the relationship between the drug and the side effect could be made with the existing data. Risk management strategies were discussed, however given prescribers of this type of medication, namely dermatologists, may not be familiar with screening and diagnosing SIB, even the most restrictive REMS may not be completely mitigate the risk.
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several types of IL-17 to the receptor. This prevents the body from receiving signals that may result in inflammation.
Data from three Phase 3 studies (AMAGINE clinical program) demonstrated the efficacy of brodalumab 210mg in total skin clearance vs. placebo in patients with psoriasis. Its superiority to ustekinumab at Week 12 was seen in two replicate comparator trials that enrolled >3,500 patients. Headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea were reported as the most common adverse reactions.
The FDA will consider the Committee’s recommendation in its review of brodalumab’s biologics license application (BLA). The Prescription Drug User Fee Act (PDUFA) action date is set for November 16, 2016.
For more information visit FDA.gov.