Teva receives FDA approval for leukemia treatment

Patients can now administer the injectable Chronic Myeloid Leukemia drug at home.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) announced that the US Food and Drug Administration (FDA) has approved Synribo (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. With this approval, physicians who treat adults with chronic or accelerated phase Chronic Myeloid Leukemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors (TKIs) will now have the option to allow their patients to administer Synribo therapy at home.

Teva said that it is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of Synribo for HCPs, their patients and caregivers. This program is expected to begin early in the second quarter of 2014.

Teva Oncology VP and general manager Bill Campbell said, “Home administration can reduce the number of required doctor office visits for patients being treated with Synribo, while still maintaining close collaboration with their healthcare provider to manage their treatment regimen.”

Published by Globes [online], Israel business news - www.globes-online.com - on May 7, 2014

© Copyright of Globes Publisher Itonut (1983) Ltd. 2014

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