Sanofi MS drug Aubagio gets second approval, in Australia

Having already gained approval in the largest global pharma market, the USA, French drug major Sanofi’s (Euronext: SAN) says that its US biotech subsidiary Genzyme has received approval for its Aubagio (teriflunomide) from the Australian Therapeutic Goods Administration (TGA) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

The company notes that the TGA approval will enable health professionals to prescribe Aubagio in Australia, which is now the second country to gain marketing authorization for the treatment, following Food and Drug Administration approval (The Pharma Letter September 13). Marketing applications for Aubagio are under review by the European Medicines Agency and other regulatory authorities, says Genzyme.

“We are very pleased with the TGA approval of Aubagio that makes available a new option for health care professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment,” said Bill Sibold, head of multiple sclerosis at Genzyme, adding: “The availability of Aubagio in the USA and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally.”