WebMar 31, 2024 · The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday declined by a vote of 6-4 to recommend approval of Amylyx … WebMar 28, 2024 · The FDA does appear to have significant reservations about Amylyx’s drug, though. In briefing documents released ahead of this week’s advisory meeting, agency scientists argued that the main evidence Amylyx gathered "was not exceptionally persuasive." The staff also said it was "challenging to interpret" how the drug performed …
FDA greenlights Amylyx
WebCambridge, Massachusetts–based Amylyx has dosed the first participant in its phase 2 HELIOS clinical trial of AMX0035 focusing on Wolfram syndrome. The condition is an ultra-rare genetic disorder involving the endocrine system. Symptoms of Wolfram syndrome can include diabetes insipidus, diabetes mellitus, optic atrophy and hearing loss. WebJun 6, 2024 · A decision — originally expected by June 29 after the FDA granted priority review to the application — is now expected by Sept. 29. The extension is the result of Amylyx ‘s submission of additional analyses of trial data. This was considered a major amendment to the application by the agency, which now needs more time to complete its … plantation shutters hunter valley
U.S. FDA panel votes against Amylyx
WebJul 6, 2024 · Faced with a barrage of pleas from both clinicians and patients, the FDA will hold a second expert panel hearing on Amylyx’s AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). The Peripheral and Central Nervous System Drugs Advisory Committee declined to recommend the drug’s approval at its March meeting, … WebJun 2, 2024 · Agenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new … WebAn FDA advisory panel says the evidence supporting Amylyx’s amyotrophic lateral sclerosis drug, which amounted to just one study, isn't strong enough to warrant FDA approval. plantation shutters in birmingham al