LEAMINGTON SPA, England,
June 10, 2010 /PRNewswire/ -- Hospira
announced today that the EC has approved Nivestim(TM) (filgrastim)
for the prevention of FN, the most serious haematological toxicity
that occurs as a result of cancer chemotherapy(1). 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(TM), 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(R) in the prevention of FN, and was
as well tolerated, with a similar adverse event profile.(2)
Notes to Editors:
About Hospira
Hospira is a global specialty pharmaceutical and medication
delivery company dedicated to Advancing Wellness(TM). As the world
leader in specialty generic injectable pharmaceuticals, Hospira
offers one of the broadest portfolios of generic acute-care and
oncology injectables, as well as integrated infusion therapy and
medication management solutions. Through its products, Hospira
helps improve the safety, cost and productivity of patient care.
The company is headquartered in Lake
Forest, Illinois, United
States and has approximately 13,500 employees. The head
office for Hospira in Europe,
Middle East and Africa is in Leamington Spa, UK. Learn more at
http://www.hospira.com.
References:
1. Crawford J, Dale DC, Lyman GH. Chemotherapy-Induced
Neutropenia: Risks, Consequences, and New Directions for Its
Management. Cancer, 2004; 100(2): 228-37
2. Waller, CF et al. Biosimilar filgrastim is an effective
primary prophylactic therapy for neutropenia in patients (pts)
receiving doxorubicin and docetaxel (AT) for breast cancer (BC).
Poster presentation at the joint ECCO 15 and 34th ESMO
Multidisciplinary Congress: Abstract E15-1238, 2009.