FDA News

FDA offers Orphan Drug Designation for INNOVIVE Pharmaceuticals' Tamibarotene

(Oct 15, 2007)-- INNOVIVE Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s drug candidate Tamibarotene for the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide.

Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions. Developers of orphan drugs are granted seven years of marketing exclusivity after approval of their orphan drug product as well as tax incentives for clinical research they have undertaken. In addition, the FDA coordinates research study design assistance for developers of drugs for rare diseases and conditions, and grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan drug products.

INNOVIVE recently reached an agreement with the FDA on a Special Protocol Assessment for a pivotal Phase II study of Tamibarotene in relapsed or refractory APL. Known as STAR-1 (A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients who Have Received Prior Therapy with ATRA and Arsenic Trioxide), the open-label, non-randomized, single-arm, multi-national study will enroll 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide (either sequentially or in combination). The primary objective of the study is to determine the rate of durable complete response for Tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. INNOVIVE expects to begin enrollment in the pivotal Phase II study in the fourth quarter of 2007.

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