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Catalyst

Slingshot members are tracking this event:

Brodalumab in Moderate-to-Severe Plaque Psoriasis PDUFA set for February 16 2017

Source Link:: https://pink.pharmamedtechbi.com/PS119478/Valeants-Brodalumab-Delayed-By-FDA-As-REMS-Is-Negotiated

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Additional Information

Additional Relevant Details FDA has accepted for review the Biologics License Application (BLA) 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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.

http://ir.valeant.co...

Additional Relevant Details Update on 8 Nov 2016: PDUFA was originally set for November 16 2016, got delayed to February 16 2017

http://ir.valeant.co...

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Catalyst Date

Occurred on:

Feb 16, 2017

Occurred Source:

http://ir.valeant.com/news-releases/2017/02-16-2017-120330247

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Related Keywords Fda Acceptance, Bla Submission, Brodalumab, Plaque Psoriasis