Teva Gets Full FDA Approval for Leukemia Injection
Teva Pharmaceutical Industries announced last week that the U.S. FDA granted full approval of Synribo to treat chronic myeloid leukemia (CML).
This is good news for Teva who recently came under scrutiny by the U.S. Department of Justice for the marketing and promotion of multiple sclerosis drug, Copaxone and Parkinson's Disease treatment, Azilect.
The Leukemia drug, Synribo, had been approved in October 2012 under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug "has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients." The program provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s clinical benefit and safe use.
Synribo is a treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML.