Brodalumab Application Under Review for Plaque Psoriasis
The FDA is examining a biologics license application for brodalumab injection 210 mg as a treatment for moderate to severe plaque psoriasis.
The FDA is examining a biologics license application for brodalumab injection 210 mg as a treatment for moderate to severe plaque psoriasis.
The application for the monoclonal antibody that targets the IL-17 receptor was submitted on behalf of AstraZeneca and Valeant Pharmaceuticals.
The FDA has scheduled an action date for November 16, 2016.
The application submitted to the FDA includes data from 3 phase 3 studies, which showed that brodalumab was effective at helping patients achieve total clearance of the disease.
In 2 trials involving more than 3500 patients, patients receiving a 210 mg dose of brodalumab saw greater skin clearance than the placebo group at week 12. Brodalumab was also shown to be superior to ustekinumab.
The most common adverse effects associated with the drug are headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea.
Patients with Crohn’s disease should be cautious about the use of brodalumab.
