FDA approves Amgen's new-generation filgrastim product, Neulasta

Amgen has been granted approval in the USA for Neulasta(pegfilgrastim), a new version of Neupogen (filgrastim), its blockbuster treatment for low white blood cell counts in patients undergoing chemotherapy for cancer. The new product has been approved for reducing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies who are receiving myelosuppressive drugs.

Sales of Neupogen reached $1.3 million in 2001, but the addition of Neulasta to the franchise is expected to lift its turnover to around $2 billion by 2005, according to Amgen. Indeed, the registration of Neulasta comes at the peak of a particularly good product cycle for the US biotechnology firm, which was among only a handful of companies to launch two New Molecular Entities last year, namely the red cell stimulator Aranesp (darbepoetin alfa) and Kineret (anakinra), its interleukin-1 receptor antagonist for rheumatoid arthritis (Marketletters passim).

Amgen said it would launch the new product in early April, but would not comment on the pricing of Neulasta until it was introduced. It is expected to sell at a slight premium to Neupogen, according to analysts.