FDA Approves Treatment for Relapsing Forms of Multiple Sclerosis

Disease modifying therapy maintains effects of interferon in the body for a longer duration.

Patients with relapsing forms of multiple sclerosis have a new treatment option with a less rigorous injection schedule.

On September 15, 2014, the FDA approved Biogen Idec’s peginterferon beta-1a (Plegridy), which belongs with the same interferon class as several previously approved MS medications. The treatment, which is injected under the skin on a bi-weekly basis, is formulated to maintain the effects of interferon in the body for a longer duration.

“This new medication combines the benefits of a therapy with a long track record of successful use in MS and a well-established safety profile, with the option of a less frequent injection schedule which may prove more convenient for people with MS,” said Bruce A. Cohen, MD, Chair of the National MS Society’s National Medical Advisory Committee in a press release.

Peginterferon beta-1a offers a pegylated form of interferon, which attaches to interferon molecules allowing them to maintain biologic effects for longer periods with a less rigorous dosing regimen.

In a phase III clinical trial, the treatment was found to reduce the relapse rate significantly more than placebo in approximately 1500 patients with relapsing MS.

During the trial, researchers randomly assigned 1512 MS patients into 3 groups receiving either placebo, peginterferon beta-1a 125 mg delivered subcutaneously bi-weekly, or peginterferon beta-1a 125 mg delivered subcutaneously on a monthly basis. After a year, patients in the placebo cohort were reassigned to either the bi-weekly peginterferon group or the monthly treatment group.

After the first year, the annualized relapse rate dropped by 35.6% in the 2-week dosing group, and by 27.5% in the 4-week dosing group compared with placebo. New areas of tissue damage on MRI scans fell by 67% in the 2-week dosing group and by 28% in the 4-week dosing group.

Disability progression risk under the EDSS scale fell by 38% in both peginterferon groups.

Adverse events remained consistent with other interferon treatments. The most common side effects included injection site reactions, flu-like symptoms, fever, headache, muscle pain, chills, injection site pain, weakness, and joint pain of mild or moderate severity. A greater proportion of participants in the peginterferon group experienced an increase of liver enzymes compared with the placebo group, but there was not a discontinuation of treatment.

“It is encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,” said Timothy Coetzee, PhD, Chief Advocacy, Services, and Research Officer at the National MS Society, in a press release.