FDA Approves Roivant's LISRAYA As First And Only Targeted Therapy For Dermatomyositis

(RTTNews) - Roivant Sciences Ltd (ROIV), a biopharmaceutical company, on Thursday received approval from the U.S. Food and Drug Administration (FDA) for LISRAYA 30 mg in treating adult patients of dermatomyositis.

Dermatomyositis (DM) is a rare autoimmune disorder that causes muscle weakness and painful, pruritic skin lesions. The disease may severely impair a patient's quality of life, causing cutaneous disfigurement and extensive sensitivity to light and touch. Affected individuals often grow dependent on a chronic high dose of steroids.

LISRAYA (brepocitinib) is a first-in-class potent, small-molecule inhibitor of TYK2/JAK1 that has shown a high efficacy in DM patients by reducing the extent of skin disease, muscle weakness, and overall disease burden. The drug previously received an Orphan Drug designation from the FDA and was subject to a Priority Review.

The approval was supported by results from the Phase 3 VALOR trial, as patients were administered a once-daily dose of LISRAYA. The study met its primary endpoint as subjects showed an improvement in the myositis Total Improvement Score by Week 4, and sustained results till the 52-week endpoint.

About 55% of treated patients reported minimal or no steroid use, compared to 30% in the placebo group by the end of the study. On doses of 7.5 mg or higher, 62% of participants tapered to minimal or no steroid use, significantly more than the 38% on the placebo.

The drug was found to be effective in patients on a wide array or no background therapies and demonstrated a manageable safety profile.

Following FDA approval, LISRAYA can now be prescribed for DM patients by a medical professional anywhere in the U.S., effective immediately.

LISRAYA is further being explored in trials to treat chronic infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris.

ROIV closed Thursday at $37.58, up 2.26%. In the afterhours trade, shares are up 0.45% at $37.75.