Orphan drug designation Fast Track
MONTREAL--Angiochem announced today that the Food & Drug Association (FDA) has granted both orphan drug and fast track designation to ANG1005 a novel paclitaxel-peptide drug conjugate leveraging the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer, for the treatment of glioblastoma multiforme (GBM).
"We are pleased that the FDA supports our applications for both fast track and orphan drug designation for ANG1005 for the treatment of glioblastoma multiforme. These are important regulatory milestones for the program, " commented Dr. Jean Paul Castaigne MD CEO of Angiochem. "We will continue to work closely with the FDA as we advance ANG1005 through clinical development and the associated regulatory processes."
Fast track designation is granted by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation confers some or all of the following benefits: more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, if relevant criteria are met, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
Orphan drug status is granted by the FDA to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200, 000 people in the US annually. Orphan drug designation includes benefits such as a seven-year period of marketing exclusivity in the United States after approval. Other potential advantages come in the form of protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and fee waivers for the regulatory procedures.
ANG1005 is a novel paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells is currently in phase 2 clinical development in high-grade gliomas and brain metastasis from breast cancer.