Genzyme MS drug approved in US
pharmafile | September 13, 2012 | News story | Medical Communications | Aubagio, Genzyme, Rebif, Sanofi, Tysabri, gilenya, multiple sclerosis
US regulators have given the green light for Genzyme’s Aubagio to treat patients with relapsing forms of multiple sclerosis (MS).
It is the first time the Sanofi-owned group has had an MS drug approved – a second MS treatment Lemtrada (alemtuzumab) is also awaiting approval, but has hit problems with the FDA.
No such problem for Aubagio (teriflunomide), a once-daily oral immunomodulator which reduced relapses, slowed the progression of physical disability and reduced brain lesions in MS patients in the Phase III TEMSO trial.
Injectable therapies such as Biogen’s Avonex and Merck Serono’s Rebif still make up the majority of the MS market, so the relative convenience of its tablet form may give Aubagio some traction.
Expected to make around $500 million in peak annual sales, the drug works by blocking the proliferation and functioning of activated T and B lymphocytes which are thought to be especially damaging in MS.
“We are very excited to introduce Aubagio as a new treatment option that can make a difference in the lives of people with MS,” said Genzyme chief executive David Meeker.
Direct competition will come from Novartis’ MS pill Gilenya (fingolimod), although it has had a bumpy ride over the last year in terms of safety.
In May the FDA ruled it should stay on the market, but added new warnings to the drug after a patient died soon after taking the drug last year.
There were concerns that Gilenya can dramatically reduce a patient’s heart rate within 24 hours of taking the drug, and that this could have caused the death in November.
While this was not proven, the regulator updated Gilenya’s label to contraindicate it in patients with certain pre-existing or recent conditions or stroke, or who are taking certain antiarrhythmic medications.
Genzyme’s other MS pill Lemtrada has just been issued with a Refuse to File letter by the FDA, but if approved, analysts forecast it could make at least $700 million a year.
Adam Hill
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