Roivant Sciences Wins FDA Approval for LISRAYA in Dermatomyositis, Launches Immediately

Roivant Sciences Wins FDA Approval for LISRAYA in Dermatomyositis, Launches Immediately

FDA approval and immediate launch: Roivant’s subsidiary Priovant received FDA approval for LISRAYA (brepocitinib), a once-daily oral therapy for adults with dermatomyositis, and began commercial sales the same day.

Clinical and pricing profile: The therapy is the first targeted and steroid-sparing treatment approved specifically for dermatomyositis. Its list price is $35,000 per 30-day supply, while Phase III data showed meaningful disease responses and substantial reductions in steroid use.

Measured commercial outlook and expansion plans: Management expects “slow and steady” uptake as physicians and payers adapt, with patient assistance programs aimed at reducing out-of-pocket costs. Roivant plans to develop brepocitinib for additional indications, including non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris.

Roivant Sciences NASDAQ: ROIV said the U.S. Food and Drug Administration has approved LISRAYA, its once-daily oral therapy for adults with dermatomyositis, and that the drug has already entered commercial launch.

Matt Gline, Roivant’s CEO, called the approval a significant milestone for patients with dermatomyositis, a rare and heterogeneous inflammatory disease affecting skin, muscle and, in some cases, other organs. He said LISRAYA is the first targeted therapy approved for dermatomyositis, the first once-daily oral therapy approved for the condition, and the first treatment approved specifically with a steroid-sparing benefit in the disease.

The therapy, brepocitinib, is a TYK2/JAK1 inhibitor. Gline said it is also the first TYK2/JAK1 inhibitor approved for any indication. He noted that prior efforts to advance therapies including rituximab, Remicade and Enbrel in dermatomyositis-specific studies had not succeeded.

Commercial Launch Begins Ben Zimmer, CEO of Priovant, said LISRAYA launched commercially on the same day as its approval, approximately one month ahead of the company’s initial plan. Prescribing is open, and Priovant has already received its first prescriptions, he said.

The drug carries a wholesale acquisition cost, or list price, of $35,000 for a 30-day supply. Gline estimated that the annual net value to the company for a patient receiving a full year of therapy could be in the low-to-mid-$300,000 range after accounting for compliance, gross-to-net adjustments and other factors. He cautioned that the estimate contains substantial uncertainty because LISRAYA is the first novel therapy to launch in this disease setting.

Priovant has established the My Compass Support program to assist patients with insurance navigation and financial assistance. Zimmer said the company expects many patients to have no out-of-pocket costs, while Gline said eligible patients could pay as little as $0 per month through copay support. The company is also using a limited network of specialty pharmacies intended to provide high-touch support for rare-disease patients.

Broad Label and Clinical Data Zimmer said the FDA label provides a broad indication for adults with dermatomyositis, without restrictions based on clinical presentation, disease severity or prior treatment history. The label also does not restrict concomitant use with steroids, conventional synthetic disease-modifying antirheumatic drugs, or intravenous immunoglobulin, or IVIG. According to Zimmer, the label includes efficacy information supporting improvements in skin disease, muscle strength, physical function and overall disease burden, as well as patient-reported and physician-reported outcomes.