Amgen today announced that the U.S. Food and Drug Administration has accepted for review the supplemental New Drug Application for Otezla ® for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a Prescription Drug User Fee Act action date of December 19, 2021 . “Otezla has been prescribed to hundreds of thousands of patients with …
– Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla ® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021 .
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LEO Pharma
LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021
Monday, April 26, 2021 1:00PM IST (7:30AM GMT)
Ballerup, Denmark & Madison, N.J., United States:
Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients
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Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years
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LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.
Kailas Salunkhe- April 26, 2021, 8:17 AM EDT SHARE ON:
Amgen presented results from the Phase 3 ADVANCE trial of Otezla in patients with plaque psoriasis at the American Academy of Dermatology Virtual Meeting Experience 2021.
In the placebo-controlled trial, the drug showed improved measures of disease severity in patients, irrespective of the body surface area affected by plaque psoriasis.
Amgen (
AMGN) Executive Vice President of Research and Development, David M. Reese, M.D. said, âThese positive ADVANCE results add to the growing evidence supporting the potential benefit of Otezla in adults with mild-to-moderate plaque psoriasis.â
Reese added, âWe look forward to continuing to work with the FDA to potentially expand access to oral Otezla to adults with mild-to-moderate disease severity.â (See Amgen stock analysis on TipRanks)
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