FDA grants QIDP status to Taksta for bacterial skin infections

The FDA has granted a qualified infectious disease product designation to an investigational fusidic acid antibiotic for the prevention of acute bacterial skin and skin structure infections.

As an oral tablet formulation, Taksta (sodium fusidate, Cempra) has demonstrated activity against gram-positive bacteria, including all Staphylococcus aureus strains, such as health care-associated MRSA and community-associated MRSA.

Based on phase 2 trial results, which demonstrated comparable efficacy to standard of care IV antibiotics, Taksta is being investigated as a long-term oral treatment for refractory bone and joint infections, including prosthetic joint infections.

“Taksta is Cempra’s second antibiotic product candidate to obtain QIDP status, which should enable us to expedite its development and bring this promising drug to the patients who need it the most,” Prabhavathi Fernandes, PhD, president and CEO of Cempra, said in a press release. “Previously our lead product, solithromycin, received QIDP status, and together we view these designations as further validation of Cempra's progress in achieving its goal of becoming a leader in the global anti-infective market.”

QIDP designation makes Taksta eligible for incentives provided under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, including priority FDA review, fast-track eligibility and a 5-year extension of exclusivity under the Hatch-Waxman Act if FDA-approved. Agents can receive QIDP designation if they are meant to treat serious or life-threatening illnesses caused by certain pathogens determined by the FDA.