FDA announces orphan drug status for aNK Natural Killer Cell Therapy in Merkel Cell Carcinoma
Release Date: 11-Apr-2017
NantKwest, Inc. has recently received orphan drug designation from US Food and Drug Administration (FDA) for its leading drug candidate, activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma. NantKwest, Inc. is a pioneering, next generation, clinical-stage Immunotherapy Company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases.
Presently the drug is undergoing its clinical Phase 2 trial at clinical sites in the United States treating subjects with metastatic or locally advanced Merkel cell carcinoma. FDA Orphan Drug Designation is granted to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug status provides benefits to drug developers including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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