- Posted by ISPE Boston
- On November 1, 2018
Boston-based Paratek Pharmaceuticals has announced that the FDA has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Nuzyra, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. Paratek plans on making Nuzyra available in the first quarter 2019.
“The approval of Nuzyra is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael F. Bigham, Paratek Chairman and CEO.
The CDC estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
Paratek is also preparing a marketing authorization application for omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax. (Source: Paratek Website, 02 October, 2018)