Roivant said the FDA approved Lisraya, its brepocitinib tablet, for adults with dermatomyositis, giving the company an immediate U.S. launch in a disease that has had no targeted therapy before.
The drug is a once-daily 30 mg pill and is now available in the United States. Roivant said eligible patients may pay as little as $0 per month through its support program.
The approval is based on the Phase 3 Valor trial, described by the company as the largest dermatomyositis study ever conducted. In that 52-week study, 55% of patients on Lisraya reached both moderate or better improvement on the myositis total improvement score and minimal or no steroid use, versus 30% on placebo.
Among patients starting the trial on at least 7.5 mg a day of prednisone-equivalent corticosteroids, 62% on Lisraya tapered to minimal or no steroid use by week 52, compared with 38% on placebo. Forty-five percent discontinued corticosteroids entirely, versus 29% on placebo.
Roivant said improvements were seen as early as week 4 and were sustained through the end of the study. The company also said patients on Lisraya reported more than four times as much improvement in overall disease activity as those on placebo.
The trial also showed gains on skin disease, muscle strength and everyday function. On a measure of daily activities such as getting dressed, climbing stairs and running errands, patients on Lisraya improved while placebo patients worsened.
Roivant said the approval follows FDA priority review and orphan drug designation. The company also said it will host an investor call on Aug. 28 at 8:00 a.m. ET to discuss the approval. Following these announcements, the company's shares moved -4.39%, and are now trading at a price of $35.93. For the full picture, make sure to review Roivant Sciences's 8-K report.
