Cempra Receives QIDP Designation for Taksta

Antibiotics developer Cempra said last week the FDA granted a qualified infectious disease product designation for its investigational candidate Taksta to treat acute bacterial skin and skin structure infections.

The QIDP designation was created in 2012 and provides incentives to develop new anti-infectives, similar to priority review from the FDA and a five-year exclusivity extension under the Hatch-Waxman Act.

Taksta (fusidic acid) was successful in a Phase 2 clinical trial in patients with ABSSSI caused by methicillin-resistant Staphylococcus aureus, comparing it to Pfizer’s Zyvox — the only FDA approved oral antibiotic to treat MRSA. The Chapel Hill, N.C., company said it plans to begin a Phase 3 trial by the end of this year. Cempra also is conducting an exploratory study to test the candidate for treatment of refractory infections in bones and joints.

Last year, three other ABSSSI drugs were approved through FDA priority review after all previously received QIDP designations.

Allergan’s Teflaro is also indicated to treat commonly acquired ABSSSI.

This is the second Cempra antibiotic to receive the QIDP designation from the FDA. Its lead product, solithromycin, is being developed to treat community acquired bacterial pneumonia. — Kellen Owings