Neupogen Approved In UK For Neutropenia In AIDS

Amgen-Roche has been granted approval in the UK to sell its granulocyte colony stimulating factor product Neupogen (filgrastim) as a supportive therapy in individuals with advanced HIV infection and neutropenia. This is the first approval of this indication for any G-CSF product worldwide.

Neupogen is indicated for use in individuals with HIV infection and an absolute neutrophil count of less than 1,000/ml, to allow them to continue to receive myelosuppressive medications on schedule and at optimal doses. Many myelosuppressive treatments are given to HIV-positive patients, to combat both the virus itself and opportunistic infections. They include antivirals such as zidovudine for HIV and ganciclovir for cytomegalovirus, antibacterials like co-trimoxazole and pyri-methamine, and cytotoxic agents for HIV-associated cancers.

The approval opens the way for Amgen-Roche to seek similar approvals in other European Union member states under the Mutual Recognition system. Neupogen is currently in clinical trials in the USA for this indication.