FDA Advisory Panel Supports Paratek’s Investigational Antibiotic, PDUFA Set for October

Published: Aug 09, 2018 By

Omadacycline

Shares of Paratek Pharmaceuticals are climbing in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of the company’s intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).

Omadacycline is a novel investigational antibiotic for the treatment of ABBSSSI and community-acquired bacterial pneumonia (CABP). The committee voted 17 to 1 in favor of omadacycline as a treatment for ABBSSSI and 14 to 4 in support of it as a treatment for CABP, the company announced this morning. A final FDA decision is expected in early October. The FDA does not have to follow the guidance of its advisory committee when it comes to final approval, but it typically does.

Shares of Paratek are up more than 3 percent in premarket trading following a halt called yesterday while the advisory committee deliberated over the treatment.

Michael F. Bigham, chairman and chief executive officer of Boston-based Paratek, said omadacycline has the potential to “help address the urgent and growing need for new antibiotics to treat serious community-acquired infections.” With a once-per-day dosing, the Paratek medication may lead to early hospital discharges for patients, or allow safe and effective treatment in an outpatient setting, Bigham added.

"Today's recommendations from the Advisory Committee move us one step closer to making this important new treatment option available to patients and physicians. We look forward to working with the FDA as it considers the comments from the committee members and completes its review of the omadacycline new drug applications,” Bigham said in a statement released late Wednesday.

The FDA advisory committee looked at data from three Phase III studies of omadacycline that showed the drug hit its primary and secondary endpoints in the trials. The studies involved more than 2,000 patients. Additionally, the drug was safe and well-tolerated, Paratek said.

A modernized tetracycline, omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains, Paratek said. Omadacycline has been granted both the Qualified Infectious Disease Product designation and Fast Track designation by the FDA. The PDUFA date is set for early October. In addition to ABBSSSI and CAPB, Paratek is working with the U.S. Department of Defense to determine if omadacycline would be an effective biodefense treatment for pathogenic agents that include plague and anthrax.

Paratek said it is planning to seek marketing authorization in the European Union. The company also entered into a collaborative agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region.

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