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Category: apremilast

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks. All patients then received Otezla during an OLE phase through week 32. Results: @16wks., improvement in its 1EPs of sPGA […]

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score Otezla is […]

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.