Cubist Pharmaceuticals, Inc. 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.
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