FDA Approves Baxdela for Skin Infections

Fluoroquinolone is active against MRSA

The FDA has approved delafloxacin (Baxdela, Melinta Therapeutics) for the treatment of adults with acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible bacteria. Delafloxacin is a fluoroquinolone with activity against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). It is available in both intravenous (IV) and oral formulations.

The FDA’s approval was supported by data from two phase 3 trials in patients with ABSSSI. These studies demonstrated that monotherapy with IV or oral delafloxacin was statistically noninferior to vancomycin plus aztreonam at the FDA-designated primary endpoint of an early clinical response at 48 to 72 hours.

Delafloxacin was well tolerated, with a 0.9% discontinuation rate due to adverse events in the phase 3 studies. In addition, delafloxacin has not shown a potential for QT prolongation or phototoxicity in definitive clinical trials. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies. The 450-mg tablet is bioequivalent (area under the curve) to and interchangeable with the 300-mg IV dose and can be dosed without regard to food. There are no anticipated drug–drug interactions with delafloxacin other than coadministration with chelating agents, such as antacids.

Delafloxacin received a priority review by the FDA because of its designation as a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now Act of 2012. The QIDP designation qualifies delafloxacin for certain incentives related to the development of new antibiotics, including a five-year extension of any nonpatent exclusivity periods awarded to the drug.

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse events that have occurred together, including tendinitis and tendon rupture; peripheral neuropathy; and central nervous system effects.

Source: Melinta Therapeutics; June 19, 2017.