FDA grants orphan drug status to Singh Biotechnology
Release Date: 04-Dec-2016
Singh Biotechnology, a pharmaceutical company, announces that its SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody (sdAb) SBT-100, has been granted as orphan drug designation by US Food and Drug Administration (FDA) for the treatment of pancreatic Cancer. It has been investigated that elevated STAT3 is linked with poor prognosis of solid tumors, including tumor of the pancreas. It can be inhibited either by directly targeting the intracellular protein or indirectly, by targeting the upstream regulators of the STAT3 pathway.
The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.
For Orphan Drug Clinical Insight Reports Contact: firstname.lastname@example.org
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