Priovant launches Lisraya in US following historic FDA approval for dermatomyositis
The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.
USA—Priovant Therapeutics has received approval from the US Food and Drug Administration (FDA) for Lisraya (brepocitinib), an oral treatment for dermatomyositis, a rare autoimmune disease affecting the skin and muscles.
The approval makes Lisraya the first targeted therapy authorized in the US for adults with the condition.
Under the FDA approval, adults with dermatomyositis can receive the once-daily treatment regardless of disease activity, previous treatment, or clinical presentation.
Priovant said it plans to make Lisraya immediately available to eligible patients.
The therapy is a dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor.
The FDA has also approved its use alongside existing treatments or as an alternative to non-targeted therapies, including corticosteroids, conventional immunomodulators and intravenous immunoglobulin (IVIg).
The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.
According to Priovant, patients began experiencing improvements across multiple disease domains as early as four weeks after starting treatment.
Reducing symptoms and steroid dependence
Dermatomyositis is a systemic autoimmune disease in which the immune system attacks the skin and muscles.
The condition can cause progressive muscle weakness as well as itchy, painful and sometimes debilitating skin lesions.
Researchers estimate that approximately 18,850 people in the US are living with dermatomyositis.
In addition to improving disease symptoms, Lisraya reduced patients’ dependence on corticosteroids, which healthcare professionals commonly use to manage dermatomyositis.
After 52 weeks of treatment, 45% of patients receiving Lisraya had discontinued corticosteroids completely, compared with 29% of those receiving placebo.
Although corticosteroids can help control inflammation, prolonged use can cause serious side effects, increasing the need for treatment options that can reduce long-term steroid exposure.
Ruth Ann Vleugels, founding director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Mass General Brigham, described the approval as a “turning point” for people with dermatomyositis.
She said the treatment could provide benefits across muscle, skin and overall disease activity while reducing reliance on systemic corticosteroids.
Broader development programme
Priovant is also evaluating brepocitinib in other diseases.
The company is conducting late-stage development programmes for non-infectious uveitis, an inflammatory eye disease, while also investigating the treatment for cutaneous sarcoidosis and lichen planopilaris, conditions that can affect the skin and scalp.
Following the FDA approval, Priovant is focusing on helping patients begin treatment quickly.
The company has established a network of specialty pharmacies and launched a personalized assistance platform designed to support patients with insurance coverage, treatment-related assistance and financial support.
Through the programme, Priovant said eligible patients may pay as little as $0 per month for Lisraya.
The move comes as access to rare disease medicines remains uneven across the US.
A recent report from the National Organization for Rare Disorders (NORD) found that access to rare disease therapies varies between states, with some patients facing inadequate protection from short-term insurance plans that may exclude important treatments and benefits.
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