FDA grants orphan drug status to Sapience Therapeutics (ST-36)
Release Date: 14-Apr-2017
Sapience Therapeutics, a leading biotechnonology company dedicated to develop therapies for complicated cancer cases, declared that US Food and Drug Administration (FDA) has awarded company’s novel product protein-based therapeutic ST-36, orphan drug designation for the treatment of glioma in patients.
Gliomas are a form of malignant brain cancer that affect approximately 18,000 to 20,000 people annually in the U.S. Nearly 70 percent of gliomas are glioblastoma, the most deadly form of brain cancer. Orphan Drug Designation is granted to drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon marketing approval for the designated indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and the waiver of prescription drug user 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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