The FDA last week granted an accelerated approval to Biogen and Ionis’ Qalsody for the treatment of amyotrophic lateral sclerosis (ALS) in adult patients who have a mutation in the superoxide dismutase 1 (SOD1) gene. The antisense drug will be the first on the market to treat a genetic cause of ALS. This is the FDA’s second ALS nod in recent months — the agency approved Amylyx’s long-awaited oral therapy Relyvrio in September 2022. Relyvrio’s trial data positions it as the first ALS drug to show significant slowing in disease progression and an extension of life expectancy in adult patients. The drug currently holds covered or better status for 32% of all insured lives under the pharmacy benefit.
SOURCE: MMIT Analytics, as of 5/1/23