Israel’s Gamida Cell is getting flagged to the inside regulatory track at the FDA. The agency has handed the company – which includes Novartis as a prominent investor – its breakthrough drug designation for a top product in development, intended to provide an open door to the agency to help speed along the approval process.
BTDs are becoming quite common at the FDA. And this time its special status is being applied to NiCord, which is being developed as a replacement for bone marrow transplants.
Gamida Cell has been developing a cell graft that is made up of stem cells, progenitor cells as well as dendritic cells extracted from the umbilical cord, with an eye to stepping in when the right bone marrow donor can’t be found for patients suffering from blood cancers like leukemia or lymphoma.
Novartis has been closely involved with Gamida Cell for years now. The pharma giant reportedly passed twice on options to buy the company. But it has stepped up with minority investments, helping to fund the work in play.
The Phase III program for NiCord is slated to get underway before the end of the year. Gamida Cell has only reported some basic results from a small Phase I/I study so far, claiming rapid engraftment and signs of activity.
Said Dr. Yael Margolin, president and CEO of Gamida Cell:
“The breakthrough therapy designation creates the foundation for a joint and concerted effort between the FDA and Gamida Cell to bring this important therapy faster to patients. We look forward to continuing our close cooperation with the FDA and other regulatory agencies to a positive conclusion as we prepare for commercialization.”
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