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.
FAMPYRA is an oral potassium channel blocker which is thought to work by stopping potassium leaving the nerve cells which have been damaged by MS. This enables signals to pass down the nerve more regularly, which may allow patients to walk better.
In the two Phase III clinical trials, a significantly greater portion (p<0.001) of FAMPYRA-treated patients had a consistent improvement in walking speed when compared to placebo (34.8 percent vs. 8.3 percent and 42.9 percent vs. 9.3 percent, respectively). The increased response rate in the FAMPYRA group was observed across all types of MS included in the studies.
The FAMPYRA treated patients who had consistent improvement in the two studies experienced an average increase in walking speed of 25.2 percent and 24.7 percent compared to 4.7 percent and 7.7 percent, respectively, for the placebo-treated patients.
The majority of the study participants in these trials were also taking 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 questionnaire measuring the impact of walking impairment on a patient's ability to perform everyday activities.