Soon to be available for prescribing, Synribo has gained FDA approval for the treatment of chronic myeloid leukemia in adults.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) approval for Synribo for the treatment of chronic myeloid leukemia in adults. The will drug will soon be available for prescribing.
Synribo is an injectable drug for the treatment of chronic phase or accelerated phase of chronic myeloid leukemia in adults who have resistance and/or intolerance to two or more tyrosine kinase inhibitors. The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with the drug.
Synribo received an accelerated approval that allows the FDA 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 is designed to provide patients with earlier access to promising new drugs. Full approval is expected following submission of more mature data from pivotal analysis.
“Teva is pleased to bring Synribo to the market for patients who need additional treatment options when others have failed,” said Teva president of Global R&D and chief scientific officer Dr. Michael R. Hayden. “Synribo joins Treanda and Trisenox as important hematologic treatment options in the Teva oncology portfolio.
Published by Globes [online], Israel business news
View original Globes publication at: http://www.globes.co.il/serveen/globes/docview.asp?did=1000793387&fid=1725