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2 clusters · 15 sources · 4 days · First seen 15 days ago · Last updated 12 days ago

FDA approval of Lisraya for dermatomyositis

Overview

The U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitinib), developed by Priovant Therapeutics, as the first targeted oral therapy specifically for adults with dermatomyositis. This rare autoimmune disease is characterized by skin rashes and progressive muscle weakness.

Lisraya functions as a dual TYK2 and JAK1 inhibitor to block immune signaling pathways. Clinical data from the Phase 3 VALOR trial showed significant improvements in muscle strength, physical function, and skin activity. The treatment also demonstrated the ability to reduce corticosteroid dependence; after 52 weeks, 45% of patients using the medication discontinued corticosteroids entirely, compared to 29% in the placebo group.

Entities

Lisraya · FDA · Priovant Therapeutics · Muscular Dystrophy Association · Mimrylo

Timeline

12 days ago

[HEALTH] 7 sources
FDA approves new treatments for dermatomyositis and polycythemia vera
The FDA has approved two new therapies: Lisraya for treating dermatomyositis and Mimrylo for managing polycythemia vera, offering new targeted options for these rare conditions.
15 days ago

[HEALTH] 8 sources
FDA approves Lisraya as first targeted oral treatment for adult dermatomyositis
The FDA has approved Lisraya (brepocitinib), the first targeted oral treatment specifically for adults with dermatomyositis, offering a new option to manage muscle weakness and skin symptoms.

Sources

aijourn.com · checkrare.com · consultantlive.com · drug-dev.com · formaremedicala.ro · healthcaremea.com · kormedi.com · mda.org · medicaldaily.com · medicaldialogues.in · mychesco.com · pharmabiz.net · seekingalpha.com · stocknews.com · thebionews.net