FDA begins review of Nordlicht's multiple sclerosis pill
It is the first time the agency has accepted an application for a drug of this type in both relapsing and progressive forms of the disease.
By Meera RaghunathanPublished · 1 min read
The Food and Drug Administration has accepted Nordlicht Pharma's application for an oral multiple sclerosis treatment and set a decision date in the third quarter of next year, the company said Wednesday.
Nordlicht is seeking approval in both relapsing and primary progressive disease, supported by three Phase 3 trials. The drug reduced relapse rates by about as much as an established infusion and slowed disability progression by 23% against placebo in the progressive study.
Safety remains the open question. Elevated liver enzymes led to a partial clinical hold in 2024, which was lifted after the company added monthly blood tests. Analysts expect the agency to convene outside advisers before deciding.
