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Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis
Jan. 25, 2016 09:27AM PST
Life Science Investing
Valeant Pharmaceuticals International, Inc. (NYSE:VRX, TSX:VRX) announced that the US. FDA has accepted for review the Biologics License Application submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg
Valeant Pharmaceuticals International, Inc. (NYSE:VRX, TSX:VRX) announced that the US. FDA has accepted for review the Biologics License Application submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis.
According to the company’s press release:
The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted that brodalumab has an effective mechanism of action that could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210 mg dose, brodalumab was shown to be effective in total skin clearance of psoriasis compared to placebo and superior to ustekinumab, a leading approved psoriasis treatment, at week 12 in two replicate comparator trials involving over 3,500 patients.