FDA approves first oral MS treatment

FDA has approved fingolimod (Gilenya, Novartis), 0.5 mg daily, as a first-line treatment to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). It is the first oral MS treatment approved in the United States.

Fingolimod reduces the frequency of MS relapses and helps slow the build-up of some of the physical problems caused by the disease. In clinical trials, fingolimod has a well-studied safety and tolerability profile, which has been characterized in more than 2,600 clinical trial patients, some of whom are in year 7 of their treatment, with more than 4,500 patient-years of experience.

In clinical trials, fingolimod showed superior efficacy by reducing relapses by 52% over 1 year compared to interferon beta-1a IM, a commonly prescribed injectable treatment, according to a statement from Novartis.

Fingolimod’s approval was based on the largest clinical trial program ever submitted to date to FDA for a new MS drug and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected in people with relapsing forms of MS.

According to Formulary Editorial Advisor Craig I. Coleman, PharmD, associate professor of pharmacy practice, University of Connecticut School of Pharmacy, fingolimod has been shown to be an effective oral alternative to injectable agents for reducing the rate of relapse in patients with MS.

The most frequent adverse reactions reported by patients taking fingolimod in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes, and cough.

“However, serious infectious, ophthalmic, pulmonary, and oncologic safety concerns have arisen during the drug’s development; necessitating prescribers to closely monitor patients receiving the drug and the medical community to assure vigorous post-marketing surveillance,” Dr Coleman said.

The drug will be available in 0.5-mg capsules. For more information, go to http://formularyjournal.modernmedicine.com/fingolimod.