FDA approves Lisraya, the first oral drug indicated for adult dermatomyositis

The U.S. Food and Drug Administration on August 27, 2026, approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. The FDA page calls it the first FDA-approved oral treatment option for the disease and a once-daily oral tablet that works as a Janus kinase (JAK/TYK2) inhibitor. Roivant Sciences Ltd. (Nasdaq: ROIV) furnished a Form 8-K the same day under Item 7.01, accession 0001140361-26-034735. That current report says the New Drug Application was submitted by its subsidiary Priovant Therapeutics, Inc., and that a copy of the press release is attached as Exhibit 99.1. The exhibit says LISRAYA is available immediately in the United States. The FDA page reports a higher average Total Improvement Score at week fifty-two on thirty milligrams versus placebo. It does not print that average as a number.

This is a same-day FDA approval, not a results recap. The FDA page and Roivant’s furnished exhibit print two “first” sentences on two tables. On the FDA page, Lisraya is the first oral drug indicated to treat dermatomyositis in adults and the first FDA-approved oral treatment option; it is a Janus kinase (JAK/TYK2) inhibitor. On Roivant’s furnished Exhibit 99.1, LISRAYA is a first-in-class TYK2/JAK1 inhibitor and the first and only targeted therapy approved for dermatomyositis. The FDA page does not call the drug first-in-class or first-and-only targeted. The 8-K wrapper records the announcement under Item 7.01 Regulation FD Disclosure. The information furnished under that item, including Exhibit 99.1, is not deemed filed. The FDA page does not name VALOR or call the study the largest dermatomyositis trial. Those company lines stay on the exhibit.

What the FDA approved

The FDA news release is dated August 27, 2026. It says the agency approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults, and that for decades patients had limited treatment options. The FDA page calls it the first oral drug indicated to treat dermatomyositis in adults and the first FDA-approved oral treatment option for the disease. Dermatomyositis is described there as a rare autoimmune disease in which the immune system attacks the muscles and skin, causing chronic inflammation, progressive muscle weakness, and distinctive skin rashes. Lisraya is a once-daily oral tablet that works as a Janus kinase (JAK/TYK2) inhibitor. By blocking JAK pathways, which play a key role in the body’s immune and inflammatory responses, Lisraya helps reduce the harmful inflammation that damages the muscles and skin, the page says.

“For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases,” said Nikolay Nikolov, M.D., Director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is a meaningful step forward, giving patients and their healthcare providers an approved oral therapy proven to help manage this rare and debilitating disease.” That quote stays on the FDA page. It is not a Roivant quote.

The FDA granted Lisraya Orphan Drug and Priority Review designations. The approval of Lisraya for the treatment of dermatomyositis was granted to Priovant Therapeutics Inc. The FDA page does not print a pediatric indication. This page does not invent one.

What the FDA page says about the trial

Efficacy and safety were evaluated in a phase 3 randomized, double-blind, multicenter, placebo-controlled study, NCT05437263, that included two hundred forty-one adults with dermatomyositis. Participants were randomized to Lisraya (brepocitinib) thirty milligrams once daily, brepocitinib fifteen milligrams once daily, or placebo for a fifty-two-week treatment period. The study measured Total Improvement Score at week fifty-two, a standardized scoring tool that tracks changes across six areas: muscle strength, physical function, skin and other disease activity, muscle enzymes, and both physician and patient assessments of overall health.

Participants treated with Lisraya thirty milligrams had a higher average Total Improvement Score at week fifty-two compared with placebo. The FDA page does not print that average as a number. This page does not invent one. Those participants also showed improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week forty-eight.

Some of the most common adverse reactions on the FDA page were upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. Discontinuation due to adverse reactions occurred in six percent of participants treated with Lisraya thirty milligrams, compared with eleven percent of those given placebo.

The boxed warning

The FDA page says Lisraya carries a boxed warning for serious infections, increased all-cause mortality (a higher risk of death from any cause), malignancies (cancers), major adverse cardiovascular events (serious heart and blood vessel problems), and thrombosis (blood clots). That is the FDA sentence used here. This page does not add prescribing-information lines the FDA page does not print.

What Roivant said

Roivant’s Item 7.01 8-K identifies the registrant as Roivant Sciences Ltd., a Bermuda company, with Common Shares trading as ROIV on the Nasdaq Global Select Market. Principal executive offices are 7th Floor, 50 Broadway, London SW1H 0DB, United Kingdom. Date of Report is August 27, 2026. Keyur Parekh, Authorized Signatory, signed the 8-K the same day. Item 7.01 says the company issued a press release announcing that the FDA had approved the New Drug Application for LISRAYA (brepocitinib) for the treatment of adults with dermatomyositis submitted by the company’s subsidiary, Priovant Therapeutics, Inc. Exhibit 99.1 is furnished.

The exhibit’s “first” sentence is not the FDA’s. It says LISRAYA, a first-in-class TYK2/JAK1 inhibitor, is the first and only targeted therapy approved for dermatomyositis. That sentence stays on the exhibit. The FDA page does not print it.

Matt Gline, CEO of Roivant, said: “We are hopeful the approval of LISRAYA in DM will be the first of many for brepocitinib, and will provide an important new treatment option for these patients.” He added that the company remains focused on advancing late-stage programs in non-infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris. Those other programs are company-said pipeline language. They are not FDA approvals on this page.

The exhibit calls the supporting study the Phase 3 VALOR trial and “the largest DM trial ever conducted.” The FDA page does not name VALOR and does not print “largest.” Benefits on the myositis Total Improvement Score, the exhibit says, were seen as early as week four, increased over time, and were sustained to the end of the fifty-two-week study. Most patients treated with LISRAYA were able to achieve both moderate or better improvement on the Total Improvement Score and minimal or no steroid use by the end of the study: fifty-five percent, compared with thirty percent on placebo. Among patients receiving LISRAYA who were taking at least seven and a half milligrams a day, prednisone-equivalent, of oral corticosteroids at baseline, sixty-two percent tapered to two and a half milligrams a day or less by the end of the fifty-two-week study, compared with thirty-eight percent on placebo; forty-five percent came off corticosteroids entirely, compared with twenty-nine percent on placebo.

The exhibit’s longer common-adverse-reaction list, which stays company-only, is upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.

The exhibit says LISRAYA is available immediately in the United States. Eligible patients may pay as little as zero dollars per month through the LISRAYA My Compass Support program. That is a company copay-support line for eligible patients. It is not a wholesale acquisition cost, and it is not a statement that every patient pays zero.

Roivant said it will host an investor call to discuss these updates on August 28, 2026, at 8:00 a.m. ET. That call had not happened when this page was sourced. This page does not recap it.