FDA Approves New Treatment Regimen for Multiple Sclerosis

Millions of patients with relapsing forms of multiple sclerosis won’t have to endure daily injections any longer, thanks to a new drug application approved by the U.S. Food and Drug Administration on January 28.

The FDA gave the green light to a new treatment regimen that calls for a higher dose of Copaxone (glatiramer acetate injection, Teva Pharmaceuticals) fewer times per week for patients with relapsing forms of MS.
____________________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
FDA Approves New Treatment Regimen for Multiple Sclerosis
Smoking Increases Disease Progression in Multiple Sclerosis
____________________________________________________________________________________________________________________________________________________________________

As a daily injectable at the 20 mg/mL dose, the drug has been a mainstay in MS treatment for nearly two decades and ranks as the most prescribed treatment for MS.

“Copaxone is widely accepted to be the safest of all current MS therapies,” says Omar Khan, MD, professor and chair of neurology at the Wayne State University School of Medicine in Detroit. “Thus, with the availability of a new regimen that includes a 3-times-a-week option, it will allow patients to continue with this therapy in a more convenient fashion.”

The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) Study, which Khan oversaw as the global principal investigator.

In the double-blind study conducted at 142 sites in 17 countries, about 1,400 patients with relapsing remitting MS were randomized to receive a placebo or subcutaneous injections of 40mg/mL of Copaxone three times a week.

The new dose and frequency demonstrated a favorable safety and tolerability profile and was associated with a 34% reduction in the risk of confirmed relapses at 12 months.

“By reducing the frequency of injections from 7 to 3, this peptide-based therapy maintained its efficacy and also reduced the frequency of side effects,” Khan says. “The new therapies for MS, including oral agents, are also very appealing—but virtually all of them present with different levels of side effects, including compromised immune system. However, Copaxone does not have any of those side effects.”

According to drug manufacturer Teva, the company began distributing the new three-times-a-week Copaxone formulation immediately and has patient support ready to help patients switch to the new product. The 20 mg/mL formulation of Copaxone will also remain available.

—Colleen Mullarkey

Reference

Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R; GALA Study Group. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013 Jun;73(6):705-13.