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news.Biogen Idec has received positive opinion for conditional approval from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its FAMPYRA.
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FAMPYRA is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine).
The CHMP recommended the conditional marketing authorisation of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) who have walking disabilities.
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.
In the two Phase III clinical trials majority of the study participants were using immunomodulatory drugs, including interferons, glatiramer acetate, and natalizumab; however the magnitude of improvement in walking ability was independent of concomitant therapy.
Patients confirmed the clinical meaningfulness of improved walking using the 12-item Multiple Sclerosis Walking Scale (MSWS-12), a patient-based assessment that measures the impact of walking impairment on the patient’s ability to perform everyday activities.
Fampridine was developed by Acorda Therapeutics which markets the drug in the US under the trade name AMPYRA (dalfampridine) Extended Release Tablets, 10 mg.
Biogen Idec plans to commercialize and further develop the product outside of the US under a licensing agreement with Acorda.
Acorda Therapeutics CSO Andrew Blight said they are pleased that the CHMP decision is expected to soon make FAMPYRA available to patients in Europe.