EC approves Nivestim for prevention of FN

Jun 10 2010

Hospira announced today that the EC has approved Nivestim™ (filgrastim) for the prevention of FN, the most serious haematological toxicity that occurs as a result of cancer chemotherapy. Nivestim now has marketing authorisation in all EU member states. Nivestim is expected to reduce the cost of neutropenia treatment.

Dr Cornelius Waller, Associate Professor of Internal Medicine at the Freiburg University Medical Center, Germany, said: "The approval of Nivestim offers tangible benefits to healthcare professionals and patients alike. Neutropenia that occurs as a result of cancer chemotherapy can result in patients being unable to complete their full course of chemotherapy. Nivestim provides healthcare professionals with a cost-effective, easy-to-use option to keep patients on track."

Nivestim is Hospira's second biosimilar. The company's biosimilar erythropoietin, Retacrit™, is currently available in 17 European countries, and Hospira is the first US-headquartered company to market biosimilar drugs in Europe. The company's biosimilar pipeline, one of the largest in the industry, also includes pegfilgrastim, a longer-acting version of filgrastim.

"As part of Hospira's continued commitment to expand its biosimilar portfolio, we are proud to announce that Nivestim has received licence approval from the EC," said Ron Squarer, chief commercial officer, Hospira. "Nivestim addresses unmet needs of patients and healthcare professionals through a unique combination of features that enhance convenience and safety, while reducing the cost of treatments."

Nivestim is a new filgrastim available in three presentations – 48 MU (480 mcg), 30 MU (300 mcg) and the unique 12 MU (120 mcg) low weight presentation. All presentations are available in a pre-filled syringe, allowing patients to self-administer Nivestim at home, thus conserving valuable healthcare resources. Each syringe has an integrated needle-safe device to facilitate safer administration and is individually blister-packed to reduce the risk of contamination and provide tamper-evidence.

In a large, randomised Phase lll study, Nivestim demonstrated comparable efficacy to Neupogen® in the prevention of FN, and was as well tolerated, with a similar adverse event profile.