DLBCL receives FDA orphan drug designation for eFT508
Release Date: 15-Apr-2017
US Food and Drug Administration has announced orphan drug designation to eFT508, a highly selective inhibitor of MNK1 and MNK2 for the treatment of diffuse large B-cell lymphoma. The drug is developed by eFFECTOR Therapeutics. The company has initiated to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of the agent in patients with B-cell hematologic malignancies. The company also is conducting a phase 1/phase 2 dose-escalation trial of eFT508 in patients with solid tumors.
The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
“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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