Category: apremilast

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

Acceptance, Amgen, apremilast, FDA, Otezla, Plaque Psoriasis, regulatory, sNDA, US / May 6, 2021 May 6, 2021

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

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

Adults, Amgen, apremilast, FDA, Mild, Moderate, Otezla, Plaque Psoriasis, regulatory, reports, sNDA, Submission, US / February 23, 2021 February 23, 2021

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 …

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

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

AbbVie, Amgen, apremilast, BioPharma, biopharma nl, California, cenicriviroc, coronavirus, Covid R&D Alliance, COVID-19, Daily, Firazyr, Food and Drug Administration, I-SPY COVID-19, icatibant, Otezla, Policy, QuantumLeap Healthcare Collaborative, SARS-CoV-2, SYN, Takeda Pharmaceutical, Thousand Oaks, Top Story / August 3, 2020 August 3, 2020

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.