ForCast Orthopedics Receives QIDP Designation From FDA
DENVER, February 28, 2023 (Newswire.com) - ForCast Orthopedics today announced that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ForCast's lead program, FC001, for the treatment of periprosthetic joint infection (PJI).
PJI is a rare but serious complication of joint replacement procedures that can threaten the function of the joint, the preservation of the limb and even the life of the patient. PJI is challenging to treat because the infecting bacteria adhere to the prothesis and form a protective biofilm that can be resistant to standard systemic antibiotics.
FC001 is being developed to address these challenges by delivering a targeted antibiotic therapy directly into the infected joint using ForCast's proprietary technology.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antifungal and antibacterial drugs that treat serious or life-threatening infections. These incentives include Fast Track designation, priority review, and additional market exclusivity if the product is approved by the FDA.
"We are very pleased to receive QIDP designation from the FDA," said Peter Noymer, PhD, Executive Chairman and CEO of ForCast Orthopedics. "This represents an important milestone for the company as we progress our lead product through development and toward commercialization."
"This is an exciting step forward for ForCast," added Jared Foran, MD, Chief Scientific Officer and co-founder of ForCast Orthopedics, "and one that validates our commitment to making better therapies available sooner for PJI patients."
About ForCast Orthopedics
ForCast is a development-stage company with a focus on pioneering the treatment of periprosthetic joint infection (PJI) with targeted antibiotic therapy. Our mission is to modernize the standard of care for PJI and improve the quality of life for the growing population of joint replacement patients.Contact Information:
Executive Chairman and CEO
Original Source: ForCast Orthopedics Receives QIDP Designation From FDA