BioPartners withdraws MAA application for Biferonex
Swiss biopharmaceutical firm BioPartners has withdrawn its application to the European Medicines Agency for Biferonex (interferon beta-1a), solution for injection, prefilled syringes for subcutaneous administration to treat patients with relapsing-remitting multiple sclerosis characterised by two or more exacerbations of neurological symptoms in the previous two years.
The application was submitted in July 24, 2007, but, in February, 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 Committee at the time of the withdrawal.
Evidence "would not have changed CHMP's mind"
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