Aubagio Becomes 1st Once-daily Oral DMT for Relapsing MS Patients in India

Aubagio (teriflunomide) has become the first once-a-day, oral disease-modifying therapy (DMT) for multiple sclerosis (MS) to be approved for use in India.

Sanofi Genzyme’s therapy is indicated for first-line treatment of relapsing MS. It should be taken each day with or without food, and patients in India will have access to Aubagio tablets at a 14 mg dose each.

“This product has the potential to offer an efficacious and convenient treatment regimen … vis-à-vis common treatment options that are injectables,” N. Rajaram, MD, Sanofi India’s managing director, said in a press release.” With Aubagio (teriflunomide, 14 mg), we reiterate Sanofi Genzyme’s commitment to improve and empower the lives of people with debilitating diseases in India.”

According to the Multiple Sclerosis Society of India, more than 200,000 people are living with MS in the country.

Rajaram mentioned that greater awareness of the disease and access to better diagnostic facilities have led to an increase in MS diagnoses in India.

According to Sanofi Genzyme, Aubagio has nearly 13 years of proven clinical efficacy, safety, and tolerability data.

The medication works by blocking an enzyme called dihydroorotate dehydrogenase, which is key for the proliferation and maturation of immune T- and B-cells. Both these cells are involved in inflammatory reactions believed to induce loss of the protective myelin layer (the hallmark of MS), with subsequent damage in nerve fibers.

“When taken daily, Aubagio (teriflunomide, 14 mg) reduces the number of overactive immune cells that cause the disease flare-ups, while still allowing normal immune cell activity to occur,” said Shalini Menon, MD, Sanofi’s head of medical affairs for India & South Asia.

Menon also highlighted results from studies showing Aubagio’s consistent efficacy in “reducing relapse frequency, delaying the accumulation of physical disability and arresting further decrease in brain volume.” Also, “given its convenience as an oral medicine,” Menon added, Aubagio “encourages people with multiple sclerosis to continue with long-term treatment.”

Aubagio was approved by the U.S. Food and Drug Administration in 2012, and by the European Comission in 2013. The therapy is now available in more than 81 countries.