Treanda treats indolent B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for Treanda through October 2015 for the treatment of indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Treanda had net sales of $531 million in the US in January-September.
Orphan drug status is granted to therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the US.
With the previously granted six months of pediatric exclusivity for Treanda, regulatory exclusivity for this indication is now extended through April 2016. Treanda is also indicated for the treatment of patients with chronic lymphocytic leukemia, for which it has orphan drug exclusivity through March and pediatric exclusivity through September 2015.
"Since 2008, Treanda has played a significant role in the treatment of patients with iNHL that has progressed,” said Teva Oncology VP and general manager Bill Campbell.
Published by Globes [online], Israel business news - www.globes-online.com - on November 27, 2013
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