BioPartners GmbH Withdraws Its Application For Biferonex (interferon Beta-1a)

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 31 May 2009 - 0:00 PDT

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The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw its application for Biferonex (interferon beta-1a), 6 million-international-unit solution for injection, prefilled syringes for subcutaneous administration.

Biferonex was expected to be used to treat patients with relapsing-remitting multiple sclerosis characterised by two or more exacerbations of neurological symptoms in the previous two years.

The application for the marketing authorisation for Biferonex was submitted to the Agency on 24 July 2007. On 19 February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.

The company stated in its official letter that its decision to withdraw the application was based on the fact that the additional information provided in support of the re¬examination had not changed the Committee's view on the benefit-risk balance of Biferonex.

More information about Biferonex and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency's website after the next CHMP meeting of 22-25 June 2009.

Notes

1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
2. This press release, together with other information on the work of the Agency, can be found on the Agency's website: http://www.emea.europa.eu

Source
EMEA