Vanda wins EU orphan status for imsidolimab

• Vanda Pharmaceuticals received European Commission orphan designation for imsidolimab as a potential treatment for generalized pustular psoriasis.
• The designation follows a positive opinion from the EMA Committee for Orphan Medicinal Products and is the first EU orphan designation for a GPP treatment, according to Vanda.
• Vanda stated that imsidolimab’s Biologics License Application for GPP is under FDA review with a target action date of December 12, 2026.

Vanda Pharmaceuticals (NASDAQ:VNDA) announced that the European Commission granted orphan designation to imsidolimab for the treatment of generalized pustular psoriasis, following a positive opinion from the EMA Committee for Orphan Medicinal Products.

The designation applies to imsidolimab, an investigational medicine being developed for GPP, a rare inflammatory skin condition with limited treatment options.

Vanda stated that EU orphan designation may provide benefits, including regulatory protocol assistance, reduced fees, and market exclusivity after approval, while imsidolimab already holds orphan status in the United States and Japan.

Vanda stated that the designation supports the ongoing development program for imsidolimab.

The company added that a Biologics License Application for imsidolimab in GPP is currently under review by the U.S. Food and Drug Administration, with a target action date of December 12, 2026.

Vanda Pharmaceuticals develops therapies for neurological, psychiatric, and inflammatory conditions, with imsidolimab being evaluated as a potential treatment for rare inflammatory diseases.