The biotech firm Roivant and its spinout Priovant said Wednesday that their immune-modifying drug brepocitinib outperformed a placebo in treating dermatomyositis, a skin condition that affects about 50,000 Americans.

Roivant and Priovant said they would file for approval with the Food and Drug Administration in the first half of next year.

Patients who received a 30 milligram dose of brepocitinib had a total improvement score, a measure of reduction in disease severity, of 46.5 compared to 31.2 for placebo, a statistically significant result.

Dermatomyositis is an inflammatory condition marked by debilitating muscle weakness and skin lesions that can make it difficult to climb stairs or get dressed.

“We are thrilled with the results of the VALOR study, and I would like to thank all of

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