Pharmaprojects R&D Pipeline News Feed
Gamunex becomes first ever US-approved therapy for CIDP
18 Sep 2008
Gamunex has become first therapy ever to be approved in the US for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). It also becomes the first immune globulin intravenous (IVIG) therapy approved in the US for any neurological disorder and received orphan drug status as well for this debilitating and medically-unmet disease.
CIDP is a progressive weakness and impairment of sensory function in the arms and legs, due to damage to the myelin sheath of the peripheral nerves. It is estimated to affect 2-7 out of every 100,000 people worldwide. Gamunex contains purified antibodies from the blood plasma of thousands of people, which helps limit peripheral nerve damage and improves neurological function through its immunomodulatory effects. Lawrence Stern, president and CEO of Talecris Biotherapeutics expressed their pride of being the 'first company to prove the efficacy of an IVIG therapy product for CIDP'.
CSL's Privigen and Baxter's Kiovag are both IVIG therapies currently approved in Europe for the closely related CIDP disease, Guillain-Barre syndrome, with launches expected in late 2008.
