Thursday, September 13, 2012

Aubagio (Teriflunomide) Approved by USFDA for Multiple Sclerosis

Sanofi has received USFDA approval for its relapsing remitting multiple sclerosis treatment Aubagio.  The approval has come with a boxed warning of hepatic injury, which in my view will curtail its competitive potential. Except for an oral route of administration there is almost no differentiation for Aubagio to garner a share. , Aubagio (teriflunomide) is a dihydroorotate dehydrogenase (DHODH) inhibitor and is the  second oral MS drug approved in the U.S. after Gilenya.

 Aubagio will not compete with Gilenya, as Gilenya is primarily being used in the second line setting, while Aubagio because of its limited efficacy and a better tolerability profile would be tried in first line. Interferons and Copaxone are the current standard of care in first line.

Other Oral Agents to reach the Market
The oral multiple sclerosis market is getting crowded as  BG-12  the third oral agent from Biogen idec is also  expected to enter the market soon.  BG-12 has shown a much better efficacy than Aubagio and is expected to become the new gold standard in the treatment of Multiple Sclerosis.. In head to head trials, BG-12 has shown a trend of superior efficacy (reduction in ARR), when compared to Copaxone, which has approximately 38% market share of MS market and is the current gold standard.

Clinical Data on Teriflunomide / Aubagio
In the TENERE study, Aubagio's was not able to show any benefit over Rebif in  reduction in annualized relapse rate (ARR).  In another Phase III TOWER trial, once-daily 14 mg Aubagio reduced ARR by 36.3% compared with placebo. Twice-daily 240 mg BG-12 reduced the endpoint by up to 53% in Phase III trials, while 0.5 mg once-daily Gilenya reduced it by up to 54%