Release Date: 05-Sep-2021
Bionaut Labs, a company has been grated the orphan drug designation from FDA to BNL-101 for the treatment of all malignant gliomas including diffuse intrinsic pontine glioma in pediatric and adult patients. BNL-101 is a drug-device combination comprised of doxorubicin as the active drug component together with the company's Bionautandtrade; microscale robots. Gliomas is one of the most disturbing tumors for which there are few, if any, effective treatment options and for which there remains significant unmet medical need.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.