Karyopharm Therapeutics (KPTI) Announces: FDA Considers The Effectiveness And Safety Technical Sections Complete To Support Conditional Approval For The New Animal Drug Application For Verdinexor (KPT-335) To Treat Lymphoma In Client Owned Dogs
6/16/2014 7:35:25 AM
NATICK, Mass., June 16, 2014 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel, first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has found the effectiveness and safety technical sections complete to support conditional approval under a New Animal Drug Application (NADA) for Karyopharm's novel, oral Selective Inhibitor of Nuclear Transport (SINE) compound Verdinexor (KPT-335) for the treatment of canine lymphoma. The use of Verdinexor to treat canine lymphoma has been designated a "minor use" in accordance with the Minor Use Minor Species (MUMS) Act. This makes the product eligible for conditional approval similar to orphan drug/accelerated approvals used for submissions of human therapeutics.
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