FDA approved a new antibiotic to treat community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
In addition, Paratek Pharmaceuticals, the manufacturer of omadacycline (Nuzyra) received acceptance of its submission of omadacycline to the European Medicines Agency (EMA).
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.
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The new antibiotic will be available in the first quarter of 2019.
Drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States, according to the CDC. 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, according to a Paratek statement.
"In the face of ever-increasing antibiotic resistance…we are excited to bring to physicians an effective, well-tolerated monotherapy option for patients," said Evan Loh, MD, president, COO, and chief medical officer of Paratek, in a statement from the company.
Nuzyra potentially helps reduce the cost of hospital stays by offering the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation, Loh added.
The approval of Nuzyra is supported by multiple clinical trials within the company's global development program. Nearly 2,000 adult patients received Nuzyra and it was found to be efficacious and generally safe and well-tolerated, Paratek said.
As part of the approval, Paratek agreed to conduct post marketing studies in CABP and pediatrics.
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