Opko receives orphan drug designation for CUR-1916 in Dravet Syndrome
Opko Health Inc., a leading pharmaceutical company has announced that US Food and Drug Administration has granted orphan drug designation for company’s oligonucleotide-based AntagoNAT (CUR-1916).
Release Date: 14-Apr-2017
Opko Health Inc., a leading pharmaceutical company has announced that US Food and Drug Administration has granted orphan drug designation for company’s oligonucleotide-based AntagoNAT (CUR-1916) for the treatment of Dravet Syndrome. Presently, the syndrome does not own any of the approved treatment. Oligonucleotides are synthetic chemical compounds consisting of mixtures of modified DNAs and RNAs.
Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in the U.S. and provides certain incentives for medications intended for the treatment, diagnosis or prevention of rare diseases. At present, these incentives include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees.
“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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