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.