Win for Talecris' Gamunex IVIG in Inflammatory Polyneuropathy

Implications: Talecris' form of IVIG, Gamunex was studied in the largest trial of IVIG in chronic inflammatory polyradiculoneuropathy (CIDP), with more than twice as many patients moving into remission.  CIDP is a common acquired autoimmune peripheral neuropathy, which if not treated, may lead to a peripheral quadriparesis.  Gamunex showed not only a very strong treatment effect, but with a very low 0.8% incidence of serious adverse event.  This places it above other future putative B-cell therapies for CIDP in terms of tolerability.

Analysis: IVIG is a standard treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a common acquired autoimmune form of peripheral neuropathy affecting 3-7/100,000 in the general population.  The condition is particularly common in HIV patients as well as in the general population.  Presently Gamunex is FDA approved only for idiopathic thrombocytopenic purpura (ITP) and primary immune deficiency syndrome (PI).