Karyopharm Receives Orphan Drug Status For Selinexor In Acute Myeloid Leukemia

(RTTNews) - Karyopharm Therapeutics Inc. (KPTI), a clinical-stage pharmaceutical company, said its lead drug candidate, Selinexor or KPT-330 oral, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Acute Myeloid Leukemia or AML.

The designation is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.

Orphan designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and are expected to provide significant therapeutic advantage over existing treatments.

The designation qualifies a company for benefits that apply across all stages of drug development, including an accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.

Karyopharm is 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.