The FDA Approves Teva Pharmaceutical's COPAXONE For Multiple Sclerosis
By Cyndi Root
Teva Pharmaceutical Industries Ltd. announced in a press release that the Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for COPAXONE 40mg/mL. This new dose of the drug is administered three times a week. The drug delivery allows patients to take the medication less frequently. Administered subcutaneously, the drug is for people with relapsing forms of multiple sclerosis. The new formulation will be available to patients immediately.
Multiple Sclerosis
Multiple sclerosis (MS) is a disease of the central nervous system (CNS). It attacks the optic nerves, the spinal cord, and the brain. Symptoms vary and patients have different experiences. Some symptoms can be mild, but are often disabling and chronic. People have four different types of MS: Relapsing-Remitting MS, Primary-Progressive MS, Secondary-Progressive MS, and Progressive-Relapsing MS. COPAXONE treats the relapsing types of MS.
COPAXONE
COPAXONE is a glatiramer acetate injection. COPAXONE 20 mg/mL was approved in 1996. The introduction of the 40mg/mL dose allows patients to take injections less frequently. Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI 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, while reducing the number of injections by 60 percent.”
Teva plans to distribute the new formulation immediately and the company’s patient support center is ready to help patients switch to the new product. Patients can take advantage of assistance in obtaining access to COPAXONE and round the clock nursing support. People can also get assistance in learning how to administer or self-administer injections.
FDA Approval
The FDA based its approval on the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. 1,400 patients participated in the study, which showed that the 40 mg/mL dose administered three times a week significantly reduced relapse rates. Positive results were evident a year later. Additionally, patients tolerated the dose well and safety results proved favorable.
About Teva Pharmaceuticals
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company that develops new drugs and ingredients and produces specialty and generic drugs. The company is headquartered in Israel and markets drugs in over 60 countries.
Source:
http://www.tevapharm.com/Media/News/Pages/2014/1894510.aspx