Sandoz, a Novartis company, announced that the United States Food and Drug Administration (FDA) has approved its Glatopa, which the first generic alternative version for Teva Pharmaceutical's multiple sclerosis treatment Copaxone. According to reports, Glatopa has been approved as treatment for multiple sclerosis.
After the approval, now the subsidiary of Novartis could market the drug. According to reports, Sandoz developed the new drug in partnership with Momenta Pharmaceuticals, a pharmaceutical company based in Massachusetts. The drug will be helpful in treating patients with relapsing forms of multiple sclerosis (MS). Some patients with severe MS lose the ability to walk independently or at all.
While talking about the approval for Glatopa, Peter Goldschmidt, Sandoz US President, said in a statement that the recent approval of the drug by FDA reinforces Sandoz leadership in complex, differentiated generic products. It also demonstrates the company’s commitment to provide patients a full range of therapeutic options.
Teva's Copaxone was approved by FDA in 1996. Since then, the drug has been the best-selling specialty drug of the company. The drug has been sold in more than 50 countries across the globe. In 2013, Copaxone generated sales of about $4.8 billion worldwide. Last year, the federal agency of the United States Department of Health and Human Services approved a new concentrated version of Copaxone, Copaxone 40mg/mL.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, “Healthcare professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug”. Before approving the drug, the FDA ensured that the product is safe and effective, according to Woodcock.
The company has not revealed when its new drug Glatopa will be available and what will be its cost. The average cost for a one-month supply of the 20-milligram version of Copaxone is over $6,000.