The European Commission approved Retacrit on the basis of strong, compelling safety and efficacy data, as well as compliance with extensive quality, clinical and non-clinical guidelines. Retacrit has demonstrated comparable efficacy and safety to Eprex or Erypo (epoetin alfa). Hospira will launch the product in various EU countries, beginning with Germany in early 2008.
The product is manufactured and packaged in Europe using advanced technology and following good manufacturing practice standards. Hospira will offer Retacrit in a wide range of convenient pre-filled syringes, with doses ranging from 1,000 to 40,000 international units (IU).
Retacrit is being developed, manufactured and distributed under agreements between Hospira; Stada Arzneimittel and Bioceuticals Arzneimittel, a Stada-initiated company.
Michael Kotsanis, president, Europe, Middle East and Africa, Hospira, said: “We are proud to offer Retacrit to patients and healthcare professionals in Europe, because it will lead the way in establishing a well-tolerated and effective anemia treatment with significant cost savings.”