FDA approves Roivant's oral dermatomyositis drug Lisraya (brepocitinib)

The U.S. Food and Drug Administration has granted approval to Roivant's drug brepocitinib, which will be sold under the brand name Lisraya. The decision marks the first major regulatory clearance for the company's hub‑and‑spoke model.

Lisraya is an oral therapy targeting dermatomyositis, a rare inflammatory muscle disease. The approval provides patients with a new treatment option that can be taken by mouth rather than by injection.

Analysts note that the clearance could open a multibillion‑dollar revenue opportunity for Roivant if the drug gains market uptake and insurance coverage.

The company did not disclose pricing or launch timelines in the announcement.