EC Orphan Drug Designation for Cabiralizumab (FPA008) for PVNS

Release Date: 04-Feb-2017

Five Prime Therapeutics Inc. has announced orphan drug designation by European Commission for its novel therapy, Cabiralizumab (FPA008) for the treatment of tenosynovial giant cell tumour, localised and diffuse type, also known as Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium. It is rare disease affecting neoplastic joint driven by CSF1R signaling and can be associated with significant pain and debilitation.


Cabiralizumab is the antibody to be utilized in the potential treatment of PVNS, a disease for which there is no currently approved medical treatments. The EC’s designation of orphan status is granted to encourage new developments and therapies for rare diseases and disorders. Orphan status can be granted to those diseases that are rare. These incentives include protocol assistance, i.e. scientific advice specific for designated orphan medicines, and 10 years of market exclusivity once the medicine is on the market.


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