Vanda submits FDA application for rare skin disorder drug

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) submitted a Biologics License Application to the U.S. Food and Drug Administration for imsidolimab to treat generalized pustular psoriasis, the company announced Dec. 15.

The application is supported by results from two Phase 3 studies, GEMINI-1 and GEMINI-2. In the 45-patient GEMINI-1 trial, 53% of patients receiving imsidolimab achieved clear or almost clear skin at week 4, compared to 13% on placebo. The maintenance study showed patients on active therapy maintained clear skin with no flares over approximately two years.

Generalized pustular psoriasis is a rare, chronic skin disorder characterized by sudden flares of widespread pustules and systemic symptoms. The condition has prevalence estimates ranging from approximately 2 to 124 cases per million worldwide, varying by region.

Imsidolimab is a monoclonal antibody that inhibits IL-36 receptor signaling. The drug addresses deficiency in the endogenous IL-36RA regulator commonly seen in patients with the condition due to gene mutations.

"The submission of the BLA for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, president and CEO of Vanda Pharmaceuticals.

Vanda has requested priority review for the application, citing the orphan disease status and unmet medical need. If granted, priority review would establish a six-month review cycle, with potential FDA approval as early as mid-2026.

The company holds an exclusive global license for imsidolimab development and commercialization from AnaptysBio Inc. (NASDAQ: ANAB). Regulatory and patent exclusivity for the drug is expected to extend into the late 2030s.

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