EU Committee Backs Delafloxacin for ABSSSI

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended delafloxacin (Quofenix, A. Menarini Industrie Farmaceutiche Riunite) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) when other antibacterial agents commonly used for the initial treatment of such infections are considered inappropriate.

Practitioners should consult official guidance regarding the “appropriate use of antibacterial agents,” the EMA said in an opinion summary.

The US Food and Drug Administration approved delafloxacin for the same indication on June 19, 2017, as reported by Medscape Medical News.

In the United States, the product label contains a boxed warning about the risk for “disabling and potentially irreversible adverse events such as tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.”

Delafloxacin is a systemic antibacterial drug that inhibits topoisomerase IV and DNA gyrase (topoisomerase II) — two bacterial enzymes needed for bacterial DNA replication, transcription, repair, and recombination, the EMA explained.

Delafloxacin will be sold as a 300-mg powder for concentrate for infusible solution and as a 450-mg tablet.

When given intravenously, delafloxacin is as effective as intravenous vancomycin; given orally, delafloxacin is as effective as oral vancomycin plus aztreonam, according to the EMA.

The most frequently seen adverse effects are fungal infections, headache, diarrhea, nausea, vomiting, increased transaminase levels, pruritus, and injection/infusion-site reactions.

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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