FDA Fast Track is a program designed to facilitate and expedite the development and review of a new drugs that demonstrates the potential to address an unmet medical need in the treatment of a serious or life-threatening condition. The purpose of the program is to get important new therapies to the patients earlier than would be achieved through the standard approval process.
“We appreciate the FDA’s recognition of the serious and urgent need for improvements in nerve repair therapies,” said Evan Tzanis, Executive Vice President and Head of Research and Development of Neuraptive. “With no products currently available that help to restore nerve function quickly, NTX-001 offers a potentially significant improvement to the current standards of care. Fast Track designation provides several important advantages that could expedite the development of NTX-001.” In April, FDA cleared the company’s Investigational New Drug (IND) application for NTX-001.
“We are very pleased that NTX-001 has been granted Fast Track designation,” said Ivan Gergel, MD, Neuraptive’s Executive Chairman of the Board. “Not only does this make the program eligible for accelerated approval and priority review, but it also serves as an important validation that NTX-001 may fill a significant unmet medical need. We look forward to advancing this program into the clinic later this year.”
The company believes NTX-001 has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures.
Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company’s franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures.
Source: Company Press Release