USA-based Biovest International, a majority-owned subsidiary of Accentia Biopharmaceuticals, has received official notification from the Committee on Orphan Medical Products of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product designation for BiovaxID the company's autologous immunotherapy for the treatment of follicular lymphoma in the European Union.
In its letter to Biovest, the COMP noted that, while treatments for follicular lymphoma are currently available, "...justifications have been provided that autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin may be of significant benefit to those affected by the condition."
The positive opinion of the COMP has now been forwarded to the European Commission for final approval and publication in the community register.
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