Priovant nabs first FDA approval for targeted tablet in dermatomyositis

News FDA Priovant nabs first FDA approval for targeted tablet in dermatomyositis August 28, 2026 | 2 min read | Tristan Manalac Twitter LinkedIn Facebook Email Print Lisraya carries a boxed warning typical of JAK inhibitors, but otherwise has a broad label that allows use in all adults with the rare autoimmune disease, setting up the drug for blockbuster status in a few years, according to Leerink. The FDA has given the go-ahead to Priovant Therapeutics’ daily TYK2/JAK1 inhibitor tablet for the rare autoimmune disease dermatomyositis. The drug will carry the brand name Lisraya and is immediately available in the U.S.Lisraya is the first orally available targeted drug for dermatomyositis, which is typically treated with chronic steroid use, Priovant said in a Thursday release.

The first-in-class approval grants Lisraya (brepocitinib) a broad label, open for use in all adults with the inflammatory disease regardless of their clinical presentation or prior treatments, the biotech added. Lisraya can serve as an add-on to non-targeted medications for dermatomyositis or as an alternative to current options.“There are no major surprises in the label,” Leerink Partners told investors in a Thursday evening note. Lisraya carries a boxed warning for serious infections, malignancy, major adverse cardiovascular events, thrombosis and death—though the analyst firm said this was expected and in line with the broader JAK inhibitor class.Dermatomyositis is characterized by an immune system that recognizes the patient’s own muscles and skin as foreign, leading to chronic inflammation, progressive muscle weakness and distinctive skin rashes, according to the FDA’s approval announcement.

Around one in every 100,000 people develop dermatomyositis yearly. Leerink expects the roll out of Lisraya to be “slow and steady,” in keeping with prior guidance from Priovant. The analysts project 2027 worldwide dermatomyositis sales for the drug to be around $49 million, growing to $1.1 billion in 2029 and to $1.8 billion in 2032.

The analysts also model potential sales of $4.2 billion in 2032 across multiple indications as Priovant tests the drug in other conditions. Immunology and inflammation Priovant Plots Path to Phase 3 as Brepocitinib Clears Mid-Stage Skin Disease Study According to Priovant, the Phase 2 BEACON study is the first industry-sponsored placebo-controlled trial in cutaneous sarcoidosis to deliver positive data. February 6, 2026 · 2 min read · Tristan Manalac Read more Backing the approval verdict—which was secured under priority review—are data from the Phase 3 VALOR study.

A readout in September 2025 showed that Lisraya led to significantly stronger clinical response than placebo, an effect that helped “nearly twice as many patients” to discontinue background steroid treatment, Priovant said at the time.In its Thursday release, Priovant said that among patients who were on at least 7.5 mg/day prednisone-equivalents of oral corticosteroid at baseline, 45% on Lisraya were able to stop steroid treatment entirely, as compared with 29% in placebo comparators.Lisraya originally came from Pfizer, which licensed the drug out to Priovant when the pharma formed the spinoff entity with Roivant Sciences in 2022. Outside of dermatomyositis, Lisraya is also being developed for cutaneous sarcoidosis, for which Phase 2b data in February showed significant disease activity improvements. Priovant is also testing the drug out in non-infectious uveitis, with Phase 3 data expected later this year, while also running a Phase 2/3 study in lichen planopilaris.

Twitter LinkedIn Facebook Email Print Approvals Rare diseases Tristan Manalac Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.