BASEL, Switzerland An investigational drug for treating multiple sclerosis reduced progression of disability by more than 30%, according to results of a late-stage clinical trial recently published in The New England Journal of Medicine.
Novartis conducted two phase 3 trials of FTY720 (fingolimod), an oral treatment for MS, administering 0.5-mg and 1.25-mg doses to more than 2,300 patients. The Swiss drug maker applied for approval of the 0.5-mg dose with the Food and Drug Administration in December on account of its posing lower risk to patients.
In one study, which enrolled 1,272 patients and lasted for two years, patients taking the 0.5-mg dose experienced reductions in the risk of three-month and six-month confirmed disability progression by 30% and 37% compared with placebo, respectively, and got similar results from the 1.25-mg dose. In the one-year study, which enrolled 1,292 patients, the 0.5 mg dose reduced relapses by 52% compared with Biogen Idec’s Avonex (interferon beta-1a), while the 1.25-mg dose reduced them by 38%.
“Innovative science leading to new medicines for MS patients is greatly needed,” National Multiple Sclerosis Society EVP research and clinical programs John Richert said in a statement. “The positive results published in The New England Journal of Medicine showing benefit of fingolimod on the clinical and MRI outcomes assessed is very encouraging to MS patients, their families and their physicians.”