The U.S. Food and Drug Administration (FDA) has approved Teva’s supplemental new drug application (sNDA) for a new formulation for Copaxone. Copaxone is now available in 40mg/mL in a three-times-a-week dosage.
The new formulation offers physicians and patients with relapsing forms of multiple sclerosis (MS) the option to dose less frequently. Copaxone (glatiramer acetate injection) is administered subcutaneously. Daily 20mg/mL doses will continue to be available in addition to the new formulation.
North America Specialty Medicines President Larry Downey said, “For more than 20 years, Teva has pursued its multiple sclerosis research with the goal of providing effective, safe and tolerable therapies for MS patients. We have progressively invested in the innovation of Copaxone in an effort to understand the needs and to ease the burden of patients who live with relapsing forms of MS every day. Today we are proud to continue to deliver on that investment by offering the freedom to dose three-times-a-week with Copaxone 40 mg/mL.”
The FDA approved the new formulation following positive data from Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study showing that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly decreased rates of MS relapse at 12 months. More than 1,400 patients participated in the study.
Omar Khan, Professor of Neurology and Chair of the Department of Neurology at the Wayne State University School of Medicine in Detroit, Michigan said, “The availability of three-times-a-week Copaxone 40 mg/mL is a significant advancement for patients as they now have the option of effective and safe treatment with Copaxone …Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone.”
Copaxone’s daily subcutaneous injection was first approved in 1996. The drug is approved in over 50 countries worldwide including Canada, Australia, Israel, and in the EU. Copaxone’s new formulation is expected to be available in distribution outlets soon.