On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
FDA Reviewers Question Safety of AstraZeneca’s Gout Drug
(Reuters)—The U.S. Food and Drug Administration staff reviewers have raised concerns about kidney- and heart-related side effects noted in trials on AstraZeneca Plc’s gout treatment, especially at higher doses. FDA reviewers, in a preliminary review published on Wednesday, expressed concerns over higher death rates related to the side effects in patients who took the drug,…
Clinical Trials Ongoing for Brodalumab
Brodalumab, an interleukin (IL) 17 inhibitor, is currently in early clinical trials (Phase 1b and Phase 2) for a number of different autoimmune diseases.1 Amgen recently terminated its co-development and commercialization agreement with AstraZeneca for the brodalumab investigational program in trials for moderate to severe plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Amgen’s decision to…
AstraZeneca Hit after Psoriasis Drug Linked to Suicide Fears
LONDON (Reuters)—AstraZeneca’s hopes of topping $45 billion in revenue by 2023 have been dealt a blow by a problem with an experimental psoriasis drug that the drugmaker had viewed as a potential billion-dollar plus seller. Amgen, its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal…