Teva gets FDA approval of three-times-a-week Copaxone

Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) says that the US Food and Drug Administration has approved its supplemental New Drug Application for three-times-a-week Copaxone (glatiramer acetate) 40mg/mL, a new dose of its best-selling multiple sclerosis drug.

This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily Copaxone 20mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996 but is facing loss of patent exclusivity.

“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, while reducing the number of injections by 60 percent,” said Omar Khan, Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI, quoted by Teva. “Patients in the USA can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone,” he added.