FDA Approves First Oral Drug for Dermatomyositis

FDA approved Lisraya (brepocitinib) on 27 August 2026 for adults with dermatomyositis, giving the rare inflammatory muscle-and-skin disease its first FDA-approved, disease-specific oral therapy. Priovant Therapeutics, a Roivant Sciences company, said the once-daily TYK2/JAK1 inhibitor is available immediately in U.S. pharmacies.

A disease that has run on off-label management

Dermatomyositis is a rare autoimmune disease that inflames both skin and muscle, producing a distinctive rash alongside progressive muscle weakness. Until this approval, treatment leaned on corticosteroids for acute control and a rotation of off-label immunosuppressants — methotrexate, mycophenolate, azathioprine, IVIG — none of which FDA had evaluated and approved specifically for the disease. Long-term steroid exposure carries its own well-documented harms, from bone loss to metabolic disease, which is why the trial's steroid-tapering data sits alongside its disease-activity endpoint as a co-equal result rather than a secondary footnote.

What VALOR measured

VALOR was a 52-week, placebo-controlled Phase 3 trial that the companies describe as the largest dermatomyositis trial conducted to date. Its primary readout combined two things clinicians care about separately: whether disease activity actually improved, and whether that improvement held while steroid doses came down rather than staying elevated to prop up the response. On the composite measure, 55% of Lisraya-treated patients reached moderate or better improvement while on minimal steroids at week 52, against 30% on placebo. The steroid-tapering results were reported as a distinct analysis limited to patients who started the trial on at least 7.5 mg/day of steroids: 62% of Lisraya patients tapered to 2.5 mg/day or below, compared with 38% on placebo, and 45% stopped steroids entirely, compared with 29% on placebo.

A TYK2/JAK1 mechanism with a broader pipeline behind it

Brepocitinib inhibits both TYK2 and JAK1, two kinases in the same signaling family implicated in the inflammatory pathways driving dermatomyositis. Roivant and Priovant are not treating the approval as a single-indication event: brepocitinib is also in Phase 3 testing for non-infectious uveitis and cutaneous sarcoidosis, and in a Phase 2b/3 program for the scarring hair-loss condition lichen planopilaris. FDA's decision on Lisraya followed Priority Review and Orphan Drug Designation, both markers the agency reserves for therapies addressing a serious condition with an unmet need.

Access terms at launch

Priovant said eligible patients can pay as little as $0 per month through a co-pay support program the company is calling LISRAYA My Compass Support at launch. As with most first-in-category orphan drugs, list price and payer coverage terms beyond the support program were not detailed in the launch announcement.