Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biogen Idec has received approval from the Australian Therapeutic Goods Administration (TGA) for Fampyra, (fampridine) 10mg Modified Release (MR) tablet.
Subscribe to our email newsletter
Fampyra 10mg MR tablet is indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment.
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.
The results from two Phase III clinical trials demonstrated that a greater proportion of people treated with Fampyra had a consistent improvement in walking speed when compared to placebo.
The increased response rate in the Fampyra group was observed across all types of MS included in the studies.
Biogen Idec Development director Norman Putzki said they 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," Putzki said.