FDA advisers on Wednesday signaled openness to expediting an experimental drug from Biogen that targets a rare form of ALS.
Food and Drug Administration advisers on Wednesday signaled openness to expediting an experimental drug from Biogen that targets a rare form of ALS, or Lou Gehrig's disease.ALS is a progressive and fatal neurological disease that typically kills patients within three to five years of the first symptoms, and there are no approved therapies for this genetic form of the condition.
provided voted 9-0 that reduction of a protein biomarker in tofersen-treated patients likely predicts it has clinical benefit. But the panel later voted 5-3 with one abstention that clinical data from the placebo-controlled study and other results didn't provide convincing evidence of tofersen's effectiveness.the concerns shouldn't stand in the way of expedited approval, citing "regulatory flexibility" to speed new treatments to patients with life-threatening conditions when there's no satisfactory alternative.
Argentina Últimas Noticias, Argentina Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
FDA advisors reject Biogen's ALS drug for rare and aggressive form of the diseaseFDA advisors voted against Biogen's investigational ALS drug, which could become the first to target a genetic cause of the disease.
Leer más »
FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the diseaseFDA advisors voted against the effectiveness of Biogen's investigational ALS drug, which could become the first to target a genetic cause of the disease.
Leer más »
Wall Street predicts approval for another ALS drugAn FDA advisory committee is set to meet this week to discuss a drug developed by Biogen and Ionis to treat a rare form of Lou Gehrig's disease.
Leer más »
Trump live updates: Grand jury to reconvene on WednesdayA grand jury will reconvene on Wednesday to continue to weigh charges against former Pres. Trump in connection with the Manhattan district attorney's hush payment probe. See live updates here:
Leer más »
Anthony Edwards, Karl-Anthony Towns Could Return As Soon As WednesdayAnthony Edwards Karl Anthony Towns Could Return As Soon As Wednesday - RealGM Wiretap
Leer más »