FDA approves Lisraya as first targeted oral treatment for adult dermatomyositis

dermatomyositis brepocitinib JAK/TYK2 inhibitor targeted therapy autoimmune disease

The U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitinib), the first targeted oral therapy specifically indicated for the treatment of adult dermatomyositis. Developed by Priovant Therapeutics, the once-daily medication is a dual TYK2 and JAK1 inhibitor designed to block the immune signaling pathways responsible for the inflammation characteristic of this rare autoimmune disease.

Dermatomyositis is a debilitating condition marked by progressive muscle weakness and distinctive skin rashes. Historically, patients have relied on broad immunosuppressants or systemic corticosteroids, which often carry significant side effects such as osteoporosis and increased infection risk.

The approval is based on results from the Phase 3 VALOR clinical trial involving 241 adults. Patients receiving the 30mg dose showed significant improvements in the Total Improvement Score (TIS)—a composite measure of muscle strength, physical function, and skin activity—compared to those receiving a placebo. Notably, the trial demonstrated that Lisraya could help patients reduce or even discontinue their use of corticosteroids.

Entities

FDA · Lisraya · Muscular Dystrophy Association · Priovant Therapeutics

Claims

What the coverage asserts, and how many sources carry each claim.

[○ 1 SOURCE] Participants receiving 30mg of brepocitinib achieved a higher average Total Improvement Score at week 52 compared to the placebo group. www.pharmabiz.net
[● 3 SOURCES] The FDA approved brepocitinib (Lisraya) for the treatment of dermatomyositis in adults. www.pharmabiz.net · www.consultantlive.com · www.mda.org
[● 3 SOURCES] Lisraya is the first product specifically indicated for the treatment of dermatomyositis in adults. www.pharmabiz.net · www.consultantlive.com · www.mda.org
[● 2 SOURCES] The approval was based on a phase 3 randomized, double-blind, multicenter, placebo-controlled trial involving 241 adults. www.pharmabiz.net · www.consultantlive.com
[● 2 SOURCES] Lisraya is an oral Janus kinase (JAK/TYK2) inhibitor administered once daily. www.pharmabiz.net · www.consultantlive.com
[○ 1 SOURCE] The FDA granted Lisraya Orphan Drug and Priority Review designations. www.consultantlive.com