Genzyme’s new multiple sclerosis drug Aubagio (teriflunomide) has received final guidance recommendation from the National Institute for Health and Care Excellence (NICE).
Aubagio (teriflunomide) is used to treat adult patients with active relapsing, remitting multiple sclerosis (RRMS). Teriflunomide is administered as a first oral, once-daily, and first line therapy for reduction of annualized relapse rates. It is also used to reduce disability risk accumulation compared to placebo during the Phase III controlled trials. The drug is developed as a selective immunomodulatory disease-modifying treatment for MS and has compounded anti-inflammatory properties.
Aubagio provides a viable alternative to injectable first-line RRMS treatment options. Carole Longson, NICE Health Technology Evaluation Center Director, said, “As an oral treatment with a different side-effect profile, teriflunomide offers a new option for treating relapsing-remitting multiple sclerosis, which could have a substantial impact on quality of life for people with relapsing-remitting multiple sclerosis.” Director Longson added that all current treatments for MS are injectables and can be associated with disagreeable side effects.
The EU granted marketing authorization for teriflunomide based on the TEMSO (Teriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) clinical trials. During the two-year, double-blind Phase III trial, teriflunomide 14 mg decreased the annualized relapse rate in patients with RRMS by 32% (TEMSO) and 36% (TOWER) compared to placebo. The drug also reduced sustained disability accumulation risks by 30% (TEMSO) and 32% (TOWER).
Benjamin Turner, Barts Health NHS Trust consultant neurologist, said, “Teriflunomide is a simple, effective, once-daily oral medication that will be invaluable for people with MS… This approval is great news for UK patients and especially those who cannot tolerate injections, as until now there have been limited treatment options open to them.”
With NICE’s final guidance recommendation, the National Health Service (NHS) is induced to a legal obligation to begin funding treatment for eligible patients within the next three months.