In what could mark a turning point for Fate Therapeutics Inc. (NASDAQ: FATE), the FDA has issued Fast-Track designation for its drug candidate ProTmune. The drug is being developed as a therapy for reducing adverse body reaction in patients who have undergone allogeneic hematopoietic cell transplantation or HCT.
The FDA Fast-Track designation clears the way for accelerated regulatory review of a drug candidate. That is primarily done to shorten the time it would normally take to launch a new drug product on the market. But not every drug candidate gets Fast-Track status from the FDA. An experimental drug must demonstrate that it is capable of addressing an unmet medical need in patients afflicted by serious conditions before the FDA can consider assigning it Fast-Track designation.
Fate Therapeutics Inc. (NASDAQ: FATE)’s ProTmune is one such experimental drug that is promising to address an unmet medical need. The drug is specifically designed to address acute graft-versus-host disease (GvHD) in HCT patients. Acute GvHD is observed in the initial several months in patients who have undergone HCT. It is during those first months that a violent immune reaction ensues between the cells of the donor and those of the recipient.
Ineffective therapies but Fate Therapeutics Inc. (NASDAQ:FATE) offers credible solution
Although there are existing therapies to address incidents of acute GvHD, they are not effective for everyone. It is estimated that up to 50% of patients who have undergone HCT still experience the violent fight between their immune cells and those of the donors, thus resulting in a debilitating disease. Even in those patients who positively respond to the existing therapies to reduce acute GvHD incidents, the durability of the treatment can sometimes be too short to rely on.
But Fate Therapeutics Inc. (NASDAQ: FATE)’s ProTmune appears to offer significant promise in addressing incidents of acute GvHD in post-HCT procedures. With the FDA Fast-Track designation, FATE believes it now stands a better chance to launch the drug on the market.
For Fate Therapeutics Inc. (NASDAQ:FATE)’s management, the Fast-Track designation also comes as a confidence boost. According to the company’s Chief Medical Officer, Chris Storgard, the Fast-Track designation points to ProTmune’s potential to address a life-threatening condition that hampers recovery in HCT patients.