Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of its investigational antibiotic tedizolid phosphate (TR-701). Cubist is seeking approval of tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Tedizolid phosphate is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Cubist added tedizolid phosphate to its pipeline through the recent acquisition of Trius Therapeutics. Earlier this year, tedizolid phosphate was granted Fast Track status, pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, by the FDA for its Qualified Infectious Disease Product (QIDP) indications of ABSSSI, as well as Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). The QIDP designation for tedizolid phosphate allows for certain incentives related to the development of new antibiotics, including eligibility for Fast Track status, Priority Review, and if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.
The NDA submission is based on data from two Phase 3 late-stage clinical studies, called ESTABLISH 1 and ESTABLISH 2, which enrolled 1,333 people in the U.S., Europe and other regions worldwide. As has been previously reported, tedizolid met the primary endpoint and all secondary endpoints defined by the FDA.
“Globally, MRSA continues to be a significant clinical and economic burden. We believe tedizolid could offer physicians an important treatment option for people with serious skin infections where a well-tolerated, once-daily, short course of therapy would be beneficial,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Our NDA submission for tedizolid phosphate is an example of our ongoing commitment at Cubist to address the urgent need for new antibiotics in an era of increasing multidrug resistance.”