EMA issues positive opinion backing orphan drug designation for avelumab

25 November 2015

The European Medicine’s Agency’s (EMA) committee for orphan medicinal products (COMP) has issued a positive opinion backing Orphan Drug Designation (ODD) for avelumab, it has been announced.

Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer under development by Germany's Merck (MRK: DE) and US pharma giant Pfizer (NYSE: PFE).

The opinion will be forwarded to the European Commission for an official decision, which will be issued within 30 days.

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