Hospira receives CHMP backing for subcutaneous Retacrit use
23 February 2010 00:00 in Pharmaceutical Company Product News
Hospira has been given a positive recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for regulatory approval of its drug Retacrit as a subcutaneous treatment.
The drug, which is designed for sufferers of renal anaemia, was endorsed on the basis of phase III trial results demonstrating its comparable efficacy to the reference drug epoetin alfa.
This recommendation means that the European Commission is now expected to grant final approval to the new treatment option within the next few months.
Michael Kotsanis, Hospira's president of Europe, Middle East and Africa, stated that the development of Retacrit is demonstrative of the firm's commitment to providing expanded biosimilar options for patients.
He added: "This will give clinicians greater flexibility in managing symptomatic anaemia in their renal patients and provide healthcare professionals with a cost-effective alternative to originator epoetins."
Retacrit has been available in the UK in its previous specification since 2008, having been approved by the European Commission the previous year.
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