Paratek Submits pre-Emergency Use Authorization Application for NUZYRA

Paratek Pharmaceuticals announced that a pre-emergency use authorization (EUA) application for NUZYRA (omadacycline) has been submitted to the U.S. Food and Drug Administration (FDA). With a pre-EUA, FDA could allow for the potential use of NUZYRA during a declared emergency under emergency use authorization for the treatment and prophylaxis of pulmonary anthrax in a public health emergency.

The pre-EUA application was submitted by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, as part of the public-private partnership between Paratek and BARDA to develop the drug. A pre-EUA allows BARDA to procure NUZYRA to potentially be used during a public health emergency including the treatment and prophylaxis of pulmonary anthrax. 

The purchase of the first 2,500 treatment courses of NUZYRA, valued at approximately $38 million, will take place upon the acceptance of the pre-EUA, which is expected in the first half of 2020.

"At a time when current antibiotic treatment options against anthrax are limited, we are pleased that in partnership with BARDA, the pre-EUA application for NUZYRA has been completed and filed with the FDA," said Evan Loh, M.D. CEO, Paratek. "We have been studying the potential utility of antibiotics against bioterrorism threats for over a decade and have evaluated the in vitro activity and in vivo efficacy of NUZYRA against Bacillus anthracis, the causative pathogen of anthrax. We believe these promising in vitro and in vivo data combined with the well-characterized oral and intravenous pharmacokinetics, safety, and tolerability of NUZYRA provide confidence in the potential utility of NUZYRA against anthrax."   

In December 2019, BARDA awarded Paratek a 5-year contract, valued at up to $285 million, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; and 3) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.

NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

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