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EMA grants ODD to Ceptaris Chlormethine gel

The European Medicines Agency (EMA) has granted orphan drug designation (ODD) to Ceptaris Therapeutics' Chlormethine gel as a treatment for Cutaneous T-Cell Lymphoma (CTCL).

Chlormethine gel also known as mechlorethamine gel in the US will relieve the signs and symptoms of CTCL.

The initiative by EMA is intended to promote the development of products that offer potential therapeutic benefits against challenging diseases.

Ceptaris chairman and CEO Steve Tullman said the ODD will highlight the need for additional therapeutic alternatives for patients with CTCL.

"We look forward to the continued execution of our European regulatory strategy," Tullman added.

Currently, mechlorethamine gel is under review by the US Food and Drug Administration (FDA) for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of CTCL.