FDA accepts BLA for brodalumab for plaque psoriasis

The FDA has accepted to review the biologics license application for brodalumab for patients with moderate-to-severe plaque psoriasis, according to a press release from Valeant Pharmaceuticals International.

The BLA for brodalumab injection, 210 mg, a novel human monoclonal antibody that targets the interleukin-17 (IL-17) receptor, was submitted by AstraZeneca in partnership with Valeant, according to the release. A Prescription Drug User Fee Act action date of Nov. 16 was assigned by the FDA.

Data from three AMAGINE phase 3 studies were used to support the BLA. Brodalumab at 210 mg dose was effective in total skin clearance of psoriasis, when compared at week 12 with placebo, and was superior to Stelara (ustekinumab, Janssen) in two replicate comparator trials of more than 3,500 patients, according to the release.

Brodalumab prevents the body from receiving signals that may lead to inflammation by stopping IL-17 from activating the receptor, according to the release.

The European Medicines Agency accepted the Marketing Authorisation Application for brodalumab for psoriasis in the fourth quarter of 2015, according to the release.

A collaborative agreement between Valeant and AstraZeneca was announced in October 2015, in which Valeant has the exclusive right to develop and commercialize brodalumab globally, accept in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., according to the release.

Headache, arthralgia, fatigue, oropharyngeal pain and diarrhea were common adverse reactions reported with brodalumab. There should be caution in prescribing the drug to patients with a history of Crohn’s disease, and suicidal behavior and ideation have been reported, according to the release.

Reference: www.valeant.com