Late last year, Biogen disclosed results from a closely watched study evaluating an experimental drug for Lou Gehrig’s disease, also known as ALS or amyotrophic lateral sclerosis. They showed the drug, called tofersen, wasn’t better than a placebo at slowing progression of the fatal nerve disorder, dealing yet another blow to patients and caregivers, who currently have very limited treatment options.
Despite those results, Biogen recently submitted an approval application to the Food and Drug Administration and on Tuesday, the company announced the agency has agreed to review it on an expedited basis. Biogen had not previously disclosed its submission.
A verdict on approval is expected by Jan. 25, the company said.
The FDA’s decision to review comes a little more than a year after it granted approval to another Biogen drug with a mixed track record in clinical testing. Last June, the drug, which is now sold as Aduhelm, became the first in the U.S. cleared to treat Alzheimer’s disease itself rather than its associated symptoms. While historic, the approval was also exceedingly controversial, and Biogen has since all but scrapped Aduhelm as a product because of challenges getting doctors to prescribe it and insurers to pay for it.
Click here to read the full article at Biopharma Dive
Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use,
BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.