TEDIZOLID RECEIVES QIDP DESIGNATION FROM FDA (Part I)
TSRX is a coiled spring that will take off, like ACAD, once the street realizes its true value, including its QIDP designation:
San Diego, CA, January 7, 2013 – Trius Therapeutics, Inc., a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious infections, announced today that the U.S. Food and Drug Administration (FDA) has designated the company’s Phase 3 antibiotic candidate, tedizolid phosphate, as a Qualified Infectious Disease Product (QIDP). Trius received the designation for its current Phase 3 program of tedizolid for acute bacterial skin and skin structure infections (ABSSSI) as well as the planned Phase 3 program for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). In addition, the designations were granted for both the intravenous and oral dosage forms of tedizolid. The QIDP designation will enable Trius to benefit from certain incentives for the development of new antibiotics, including priority review and eligibility for fast-track status. The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act (FDASIA).
“The FDA’s QIDP designation for tedizolid is further confirmation that the GAIN Act is aimed at promoting more rapid antibiotic development, and we are pleased to receive the designation for both the intravenous and oral dosage forms of tedizolid,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer at Trius. “The tedizolid clinical program reflects our commitment to bring safe, effective and convenient therapies to people with serious infections.”