Tuesday May 31 2011 02:15 PM
European Medicines Agency’s Committee for Medicinal Products for Human Use issues positive opinion on marketing authorisation application for FAMPYRA.
Zug, Switzerland – May 20, 2011 – Biogen Idec (NASDAQ: BIIB) announced today that FAMPYRA® (prolonged-release fampridine tablets) has been granted a positive opinion for conditional approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Based on the CHMP recommendation, Biogen Idec expects that a marketing authorisation for FAMPYRA should be granted within 67 days.
“We are very pleased by the CHMP decision. Walking disability is a common symptom in multiple sclerosis patients and we are excited to offer an oral therapy in Europe to address this high unmet medical need,” said Dr. Norman Putzki, Director of Development at Biogen Idec. “FAMPYRA will offer patients, regardless of their type of MS, a novel therapeutic option to improve their walking. The conditional approval will allow us to bring this treatment to patients in European markets this summer.”
The CHMP recommended the conditional marketing authorisation of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) who have walking disabilities (Expanded Disability Status Scale of 4 to 7). FAMPYRA demonstrated efficacy in people with all types of MS, both relapsing remitting and progressive forms. FAMPYRA can be used alone or with existing MS therapies, including immunomodulatory drugs.
It may be a number of months before Fampyra could be available in Ireland. However, with funding cuts and the current difficulties funding new drugs like Tysabri it is unknown when and how Fampyra will be made available in Ireland. MS Ireland will be monitoring the situation and working with the relevant departments, groups and Biogen Idec to see the therapy introduced to the benefit of people with MS.
“We are very pleased by the CHMP decision. Walking disability is a common symptom in multiple sclerosis patients and we are excited to offer an oral therapy in Europe to address this high unmet medical need,” said Dr. Norman Putzki, Director of Development at Biogen Idec. “FAMPYRA will offer patients, regardless of their type of MS, a novel therapeutic option to improve their walking. The conditional approval will allow us to bring this treatment to patients in European markets this summer.”
The CHMP recommended the conditional marketing authorisation of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) who have walking disabilities (Expanded Disability Status Scale of 4 to 7). FAMPYRA demonstrated efficacy in people with all types of MS, both relapsing remitting and progressive forms. FAMPYRA can be used alone or with existing MS therapies, including immunomodulatory drugs.
It may be a number of months before Fampyra could be available in Ireland. However, with funding cuts and the current difficulties funding new drugs like Tysabri it is unknown when and how Fampyra will be made available in Ireland. MS Ireland will be monitoring the situation and working with the relevant departments, groups and Biogen Idec to see the therapy introduced to the benefit of people with MS.
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