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Teva receives approval for SYNRIBO for injection

Teva Pharmaceutical announced that the U.S. FDA approved SYNRIBO for Injection to treat adult patients with chronic phase or accelerated phase chronic myeloid leukemia with 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 SYNRIBO. It will be available for prescribing shortly. 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 approval is based on an analysis of combined data subsets from two Phase II, open-label, multicenter studies.