FDA Drug Approvals: Health Care Practitioners — Year in Review 2018

Mary L Windle, PharmD

Disclosures

January 18, 2019

New Antibiotics

Nuzyra (omadacycline)

The aminomethylcycline omadacycline is indicated for adults with bacterial community-acquired pneumonia (CAP). It is available for either intravenous or oral administration and is administered once daily.

Omadacycline is a modernized tetracycline with broad-spectrum activity designed to overcome tetracycline resistance. It is active in vitro against gram-positive bacteria expressing tetracycline resistance–active efflux pumps (tetK and tetL) and ribosomal protection proteins (tetM). It is indicated for treatment of community-acquired bacterial pneumonia in adults caused by susceptible microorganisms, including Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Approval was based on results of a randomized, controlled trial (n=774) in adults with CAP who required at least 3 days of intravenous antibiotics. In this trial, omadacycline was shown to be noninferior to moxifloxacin. (Prescribing information)

Xerava (eravacycline)

Eravacycline is a synthetic fluorocycline antibiotic belonging to the tetracycline drug class.

It disrupts bacterial protein synthesis by binding the 30S ribosomal subunit, thus preventing incorporation of amino acid residues into elongating peptide chains. It is indicated in adults for treatment of complicated intra-abdominal infections caused by the following susceptible bacteria: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis.

Approval for complicated intra-abdominal infections was based on results from the IGNITE-1 clinical trial (n=541), which demonstrated eravacycline to be noninferior to ertapenem. (JAMA Surg. 2017 Mar 1;152(3):224-232)

Seysara (sarecycline)

Sarecycline is a new first-in-class tetracycline-derived antibiotic indicated for adults and children aged 9 years and older with non-nodular moderate-to-severe acne vulgaris. Compared with currently available tetracyclines, it has a narrow spectrum of activity, including less activity against enteric gram-negative bacteria, and it also elicits anti-inflammatory effects.

Clinical trials showed efficacy compared with placebo to be statistically significant. Onset of efficacy, observed by improvement of inflammatory lesions, was evident at the first follow-up visit (ie, 3 weeks). (J Drugs Dermatol. 2018 Sep 1;17(9):987-996)

Zemdri (plazomicin)

The FDA approved plazomicin, an aminoglycoside, in June 2018. Approval was based on the phase 3 EPIC (evaluating plazomicin in cUTI) clinical trial (n=388). Plazomicin was noninferior compared with meropenem for clinical cure and microbiological eradication at day 5 and test-of-cure at about day 17. (EPIC clinical trial discussion)

Plazomicin has been engineered to overcome aminoglycoside-modifying enzymes, the most common aminoglycoside-resistance mechanism in Enterobacteriaceae, and it has in vitro activity against extended-spectrum beta-lactamase-producing, aminoglycoside-resistant, and carbapenem-resistant isolates. It is indicated for complicated urinary tract infections (cUTIs), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. Limited clinical safety and efficacy data are available; therefore, the prescribing information recommends reserving treatment for use in patients with cUTI who have limited or no alternative treatment options.

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