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Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis

Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis 1

Valeant Pharmaceuticals Intl: Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis. 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. 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. BRIEF-Valeant announces FDA acceptance of bla submission for brodalumab in moderate-to-severe plaque psoriasis Jan 25 (InterSignals) – Valeant Pharma.

Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis 2Cosentyx is approved by the FDA for moderate to severe plaque psoriasis in adults. The therapy is in development for patients with moderate-to-severe plaque psoriasis. Brodalumab is a human monoclonal antibody designed for the treatment of inflammatory diseases. In January 2016 a Biologics License Application (BLA) was submitted to the US FDA.

Amgen, AstraZeneca’s brodalumab meets primary endpoints of third Phase III trial in moderate-to-severe plaque psoriasis. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for plecanatide (Synergy) for the treatment of chronic idiopathic constipation (CIC). FDA Granted Priority Review for Atezolizumab BLA in NSCLC Indication. Radius Health announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for abaloparatide-subcutaneous (SC) 80mg, a once daily treatment for postmenopausal women with osteoporosis.

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Amgen, Astrazeneca’s Brodalumab Meets Primary Endpoints Of Third Phase Iii Trial In Moderate-to-severe Plaque Psoriasis