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FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant 

April 27, 2020

Carmell Therapeutics - Logo

Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that the U.S. Food and Drug Administration (FDA) last week has granted Fast Track designation for the Company’s first product, a Bone Healing Accelerant (BHA). The Fast Track designation provides the company benefits in expediting and accelerating the company’s lead program to the goal of a Biologic License Application (BLA) approval.

Carmell Therapeutics - Logo

“Receiving expedited review allows for more frequent meetings with FDA to discuss our biologic’s development plan reducing risk throughout our development process,” said Stephanie Kladakis, Ph.D., Carmell’s Chief Scientific Officer. “Also this Fast Track designation allows for a rolling review for our Biologic License Application (BLA), which means that Carmell® can submit sections of our BLA package for review by FDA as they are completed, rather than waiting until the entire application is complete as is usually required. This rolling review process allows for a significantly shorter period for approval after clinical trial completion.”

“Fast Track expedited review is awarded to aid in the development and expedite regulatory review of therapies which show promise in treating a serious or life-threatening medical condition and that address an unmet medical need” said James Hart, MD, Carmell’s Chief Medical Officer. “We are pleased to have reached this agreement with FDA.”

In December, U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug application (IND) for the Company’s first product, a Bone Healing Accelerant (BHA). This IND clearance enables Carmell® to begin enrolling patients in a pivotal study for long bone fractures to support a Biologics License Application (BLA).

“Carmell Therapeutics is now on a path to be the first company in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the current standard of care,” said Donna Godward, Carmell Therapeutics’ Chief Quality Officer.

“Pursuing a BLA approval for our Bone Healing Accelerant demonstrates Carmell’s commitment to the most robust – and ultimately most commercially valuable – regulatory pathway currently in the orthopedic/wound healing space,” said Godward.

See Full Press Release: FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant | Business Wire

Written by: Carmell Therapeutics

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