FDA approves Teva's GRANIX for self-administration

Teva
Teva

From early 2015 patients will themselves be able to administer the treatment for neutropenia, associated with leukemia.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration (FDA) has approved GRANIX (tbo-filgrastim) injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe GRANIX for home or office use.

GRANIX is a leukocyte growth factor for reducing the duration of severe neutropenia associated with leukemia and bone marrow treatment. GRANIX has been commercially available in the US since November 2013 but the currently marketed GRANIX syringe is only for administration by a healthcare professional. Teva plans to launch a new GRANIX syringe, for self-administration by patients and caregivers in early 2015.

University of Tennessee Health Science Center Division Chief of Hematology Oncology Dr. Lee S. Schwartzberg said, “In partnership with their physician, patients will be able to decide whether administering GRANIX via self-injection at home or by a healthcare professional is the right course for them. Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.”

Teva Oncology VP and general manager Paul Rittman said, “This new administration option demonstrates Teva’s continued commitment to enhancing the patient experience by providing patients, in partnership with their physician, with flexibility in their treatment regimen."

Published by Globes [online], Israel business news - www.globes-online.com - on December 23, 2014

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