FDA Clears Omadacycline (Nuzyra) for Two Infections

Megan Brooks


October 03, 2018

The US Food and Drug Administration (FDA) has approved omadacycline (Nuzyra, Paratek Pharmaceuticals) for treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infection (ABSSSI).

The FDA's Antimicrobial Drug Advisory Committee recommended in favor of omadacycline for CABP and ABSSSI in August, as reported by Medscape Medical News.

Omadacycline is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance.

It is approved for CABP caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

It is also approved for ABSSSI caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S anginosus, S intermedius, and S constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

In three global phase 3 studies involving about 2000 adults, omadacycline met all primary and secondary efficacy outcomes designated by the FDA and the European Medicines Agency and was generally safe and well tolerated, the company notes in a news release.

Omadacycline comes in intravenous and oral formulations, offering clinicians the ability to start treatment in a healthcare facility and complete treatment at home, potentially reducing hospitalizations and costs.

It is also the first and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSIs in nearly 20 years, according to the company.

Paratek expects omadacycline to be available in the first quarter of 2019.

According to the US Centers for Disease Control and Prevention, each year, an estimated 2 million people in the United States develop an antibiotic-resistant infection; such infections kill at least 23,000 people a year. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7000 deaths, while ABSSSI is responsible for more than 750,000 hospitalizations, the company notes in the release.

"Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients," Keith Kaye, MD, director of clinical research, Division of Infectious Diseases, University of Michigan, Ann Arbor, said in the release. "There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape."

Omadacycline was given priority review and had fast-track and qualified infectious disease product (QIDP) designations. QIDP designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

Full prescribing information for omadacycline is available online.

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