Synribo gets label expansion


The FDA approves Teva Pharmaceutical Industries' (TEVA) Synribo (omacetaxine mepesuccinate) injection, for subcutaneous use, to include home administration. Now chronic myeloid leukemia patients who are not responding to or cannot tolerate two or more tyrosine kinase inhibitors will now have the option of administering Synribo at home.

Teva is currently finalizing a comprehensive specialty pharmacy support program to assist in the home administration of the product. The firm expects to go live in Q2.

The label expansion will be reduce the time and effort patients have had to make when prescribed Synribo. Previously, they were required to visit their doctors twice/day for two weeks. A physician must determine if their patient is a candidate for home administration. It will not be appropriate for all patients.

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