Datapoint: FDA Approves Biogen and Ionis’ ALS Drug

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

0 Comments
© 2024 MMIT
AIS Health Staff

AIS Health Staff

Related Posts

businessman-using-laptop-computer-and-digital-tablet-analyzing-sales-data-and-graph-chart
May 22

Datapoint: CMS Extends Medicaid Redetermination Deadline

Read More
businessman-using-laptop-computer-and-digital-tablet-analyzing-sales-data-and-graph-chart
May 21

Datapoint: Aetna Shut Out of Medicaid Contract Awards

Read More
businessman-using-laptop-computer-and-digital-tablet-analyzing-sales-data-and-graph-chart
May 20

Datapoint: FDA Expands Otezla’s Psoriasis Label

Read More

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today