Teva Pharmaceuticals Industries Ltd. announced that the Food and Drug Administration (FDA) has approved the supplemental new drug application for Copaxone 40 mg/mL. The new dosing schedule of three times a week will allow a less frequent dosing treatment for those living with relapsing forms of multiple sclerosis. In addition, the daily Copaxone 20 mg/mL will also continue to be available to patients.
“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,” said Larry Downey, President, North America Specialty Medicines. “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.”
This approval is based on data from the Phase III GALA study of more than 1400 individuals, which showed that higher dose injections significantly reduced the relapse rates at 12 months and demonstrated improved safety for patients with relapsing remitting MS. The new three-times-a-week dose will be available for shipping to outlets immediately and readily accessible to patients in a few days.
For more information, patients may call Teva’s Shared Solutions at 1-800-887-8100 and make a request or have any questions answered. Shared Solutions provides 24/7 support, financial and benefit investigation for those with inquiries as well as guidance for patients who need to sort through pharmacy distribution options.