FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease

The FDA has granted accelerated approval for Biogen’s ALS drug that treats a rare form of the disease.  The approval requires Biogen to further study tofersen and verify its clinical benefits in patients with amyotrophic lateral sclerosis, also known as Lou Gehrig’s Disease.

Accelerated approval is an FDA designation that clears drugs faster if they fill an unmet medical need for serious conditions. The approval requires Biogen and its co-developer Ionis to further study tofersen and verify its clinical benefits.

If a subsequent trial confirms those benefits, the FDA can grant traditional approval for the drug.
Click here for more why the decision was made and what comes next for your patients.