The European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris Therapeutics, Inc’s investigational drug, chlormethine gel (also known as mechlorethamine gel in the US), for the treatment of Cutaneous T-Cell Lymphoma (CTCL).
Orphan Drug Designation is granted by the EMA to promote the development of products that offer potential therapeutic benefits for diseases affecting less than five in 10,000 people in the EU. Products with Orphan Drug Designation are eligible for ten years of market exclusivity in the EU upon approval.
“The EMA’s decision to grant Orphan Drug Designation to our proprietary mechlorethamine gel underscores the need for additional therapeutic alternatives for patients with Cutaneous T-Cell Lymphoma,” said Ceptaris Chairman of the Board and CEO Steve Tullman. “We look forward to the continued execution of our European regulatory strategy.”
Ceptaris’ mechlorethamine gel is currently undergoing review by the US Food and Drug Administration (FDA) for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL). The FDA previously granted Orphan Drug Status to this investigational drug. The New Drug Application (NDA) for Ceptaris' mechlorethamine gel was filed in the US in July 2011.
Ceptaris Therapeutics, Inc. is developing a proprietary gel formulation of mechlorethamine hydrochloride for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL).