Yesterday, I posted about the FDA granting Humacyte the Regenerative Advanced Therapy designation, the first of its kind, to its drug Humacyl.
There was hardly any response on this board for something that is so vitally important to Mesoblast, since the company is also pursuing such a designation for its many therapies.
Many here are pre-occupied with debating and feeding the naysayers.
Anyway, wanted to give you a quick update during my lunch-break:
Here are excerpts from Peter Marks, M.D., Ph.D., the Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. FDA (CBER oversees Regen Therapies):
1. "We have started receiving RMAT designation requests and expect that, as with Breakthrough Therapy Designation, early and frequent communication facilitated by the RMAT designation will help reduce overall product development times. We very much look forward to continuing to work with sponsors of these products and other stakeholders to help make these exciting new therapies available to those in need."
2. "The FDA’s Center for Biologics Evaluation and Research is committed to helping make regenerative medicine advanced therapies that are shown to be safe and effective available as soon as possible....."
3. "The meetings with sponsors of RMAT-designated products may include discussions of whether accelerated approval would be appropriate based on surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites"
4. "Sponsors may make such a request with or after submission of an investigational new drug application and the agency then will take action on the requests within 60 calendar days of receipt..."
I am thoroughly impressed by the commitment and the speed at which CBER and FDA have acted on the new Cures Act provision.
It is my belief that Mesoblast will be getting the RAT designation soon. Which ones? CHF and RA for sure, but according to Dr. Silviu Itsecu, LBP and Diabetic Nephropathy are candidates as well (GvHD already got the fast track designation).
https://blogs.fda.gov/fdavoice/index.php/2017/03/this-is-not-a-test-rmat-designation-goes-live/
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