FDA Approves New Dosage of Copaxone for MS

The FDA approved a new dosage of Copaxone that allows patients with relapsing-remitting multiple sclerosis to take the drug three times a week instead of daily.

The FDA approved a new dosage of Copaxone (glatiramer acetate injection), 40 mg/mL subcutaneous injection, that allows patients with relapsing-remitting multiple sclerosis (MS) to take the drug three times a week instead of daily—reducing the number of required injections by 60%. The 20-mg dose of Teva’s Copaxone remains available.

Data from the Phase II GALA study of more than 1,400 MS patients showed that the new three-times-weekly administration of Copaxone significantly reduced relapse rate at 12 months. The new formulation also showed a favorable safety and tolerability profile.

As patients transition to the new three-times-weekly Copaxone formulation from the daily-use version, Teva’s Shared Solutions patient support center is ready to assist them and their healthcare providers at (800) 887-8100.

The most common side effects of Copaxone are redness, pain, swelling, itching or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. For additional prescribing instructions and precautions, consult product labeling at www.copaxoneprescribinginformation.com.