Sanofi firm Genzyme has received approval from Health Canada for its once-daily drug Aubagio (teriflunomide) 14mg as monotherapy to treat patients with relapsing remitting multiple sclerosis (RRMS).
The drug is aimed at reducing the frequency of clinical exacerbations anddelay the accumulation of physical disability in RRMS patients.
The University of Ottawa and Ottawa Hospital Research Institute director of multiple sclerosis research unit and professor of neurology Mark Freedman said there are many patients who simply cannot tolerate injections and have had no once-daily oral medication until now.
"As a new oral treatment option, AUBAGIO is an important advancement for the MS community and may help improve quality of life for people living with this debilitating disease," Freedman said.
The approval is based on efficacy data from two Phase III clinical trials TEMSO (‘TEriflunomide Multiple Sclerosis Oral’) and TOWER (‘Teriflunomide Oral in people With relapsing remitting multiplE scleRosis’).
In the TEMSO trial, AUBAGIO 14mg reduced the annualised relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in RRMS patients.
The drug reduced the annualised relapse rate (p=0.0001), and the time to disability progression sustained for 12 weeks (p = 0.0442) was decreased compared with placebo in patients with RRMS, in the TOWER trial.
Multiple Sclerosis Society of Canada vice-president of research Karen Lee said MS impacts each person differently.
"The more treatment options that are available, the more choices Canadians living with MS have to potentially improve their overall quality of life," Lee said.
"As we learn more about MS and develop therapies that reduce the frequency and severity of relapses in relapsing-remitting MS, we hope that we’ll also uncover treatments for people whose disease is steadily progressing."
Results were recently released from the double-blind, multi-centre TOPIC study of Aubagio, which was conducted on a total of 618 patients.
Enrolled in the trial were patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of MS symptoms within 90 days of randomisation, and MRI scan demonstrating two or more lesions characteristic of MS.
The trial showed that Aubagio 14mg reduced the risk of a new clinical relapse over the two-year study period and there was a 35% reduction among patients who received the drug compared with placebo (p=0.0374).
Genzyme has also developed the MS One to One programme to provide support for individuals living with MS, their health care providers, family and loved ones by offering comprehensive support services, including reimbursement navigation and other financial assistance, patient education and compliance services, medication delivery, and facilitation of the accelerated elimination procedure.
In addition to the approvals in the US, Europe, Australia, Argentina, Chile, South Korea and Mexico for the treatment of relapsing forms of MS, Aubagio is also under review by additional regulatory authorities globally.
Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101.