May 16, 2011
The Australian Therapeutic Goods Administration (TGA) has granted approval for FAMPYRA™, (fampridine) 10 mg Modified Release (MR) tablet, for the symptomatic improvement of walking ability in adult patients with multiple sclerosis(MS) who have shown improvement after eight weeks of treatment. FAMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). FAMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.
Biogen Idec (Nasdaq: BIIB) is presently taking steps to obtain Pharmaceutical Benefit Scheme (PBS) reimbursement approval for FAMPYRA, an outcome which will benefit the MS community in Australia. While Biogen Idec follows this reimbursement procedure, FAMPYRA is expected to be available to patients with a private prescription beginning in October 2011.
“We are very pleased with the TGA’s decision to approve FAMPYRA in Australia for people with MS. Studies have shown FAMPYRA can increase walking speed by 25%, independent of the type of MS, and that this increase is associated with clinically meaningful improvements in overall walking ability” said Norman Putzki, Director Development at Biogen Idec.
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