FDA Approves Three-Times Weekly Dose of Glatopa®

Sandoz, a Novartis division, announced today that the United States Food and Drug Administration (FDA) approved Glatopa® (glatiramer acetate injection) at a three-times weekly 40-mg dose. This generic version of Copaxone®, a disease-modifying therapy (DMT) approved for the treatment of relapsing forms of multiple sclerosis (MS), was initially approved at a 20-mg daily dose. Both dosing options are given via self-injection and will continue to be available to individuals taking the medication.
Copaxone was initially approved in 1996 as a daily 20-mg injection. A 40-mg dose of Copaxone injected three-times weekly was approved by the FDA in 2014. In 2015, Glatopa was approved as the first generic version of Copaxone, given at the original 20-mg daily dose. This most recent approval allows people to have the option of choosing a three-times weekly dose of Glatopa in place of the daily dose, depending on their preferences. In October 2017, Mylan’s generic version of Copaxone was approved at both doses.

As with all of the approved DMTs for relapsing forms of MS, Copaxone has been shown to reduce the number and severity of relapses, reduce the development of new areas of inflammation as seen on magnetic resonance imaging (MRI) scans, and may show evidence of delaying disease progression and/or disability. Side effects include injection-site reactions, difficult breathing, and chest pain, as well as a brief systemic reaction occurring at least once in 10-percent of those studied.

For more information, readers may visit glatopa.com. A full range of patient support services for Glatopa is available through GlatopaCare® at glatopacare.com or by calling (855) 452-8672 (1-855-GLATOPA). Services include answering questions about insurance and eligibility for Glatopa’s $0 co-pay program, injection instruction, and 24/7 patient support through GlatopaCare nurses.

For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Susan Wells Courtney, MSAA Senior Writer

Reviewed by Dr. Jack Burks, MSAA Chief Medical Consultant