FDA Approves New Fluoroquinolone Antibiotic

Yesterday, the FDA approved delafloxacin (Baxdela) to treat acute bacterial skin and skin structure infections (ABSSSI) in adult patients.

Delafloxacin is a fluoroquinolone antibiotic that has been observed to combat both gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), according to a press release. This approval provides patients with another treatment option for MRSA infections, which are known to become drug-resistant.

The novel antibiotic is available in intravenous and oral formulations.

“The approximately 3 million patients hospitalized each year in the US with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult. Baxdela provides a treatment option for adult patients with ABSSSI based on its coverage spectrum, IV and oral dosing flexibility, efficacy and safety profile,” said Eugene Sun, MD, CEO of Melinta Therapeutics. “The approval of Baxdela demonstrates FDA’s commitment to making new and effective antibiotics available to address unmet needs for hospitalized ABSSSI patients.”

The new approval was supported by positive results from a pair of phase 3 clinical trials including patients ABSSSI. The investigators found that both formulations of delafloxacin were non-inferior to treatment with vancomycin plus aztreonam at 48 to 72 hours, according to the release.

The studies also showed that delafloxacin did not show potential for QT prolongation or phototoxicity. Overall, the novel antibiotic was well tolerated, with only 0.9% of patients discontinuing treatment due to adverse events. There were no adverse events observed to affect the liver, kidney, or in glucose regulation.

Common adverse reactions include nausea, diarrhea, headache, transaminase elevations, and vomiting. The drug, like all fluoroquinolones, comes with a Boxed Warning related to the increased risk of potentially irreversible serious adverse reactions, including tendinitis, tendon rupture, peripheral neuropathy, and central nervous system effects, according to the release.

“The FDA approval of Baxdela is a major milestone for Melinta. We are grateful to the patients, families, investigators and their staffs for their support in developing an important new therapy. We want to thank the Melinta team for its leadership in bringing the first of what we believe will be many innovative antibiotics to patients,” said Kevin Ferro, CEO of Vatera Healthcare Partners, Melinta’s largest investor.

Delafloxacin was designated as a qualified infectious disease product (QIDP), which is given to antibacterial products that treat serious infections, according to the release. As part of the QIDP designation, the drug received priority review and fast track designation.

“Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine. Approval of new therapies like Baxdela, which is effective against MRSA and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients,” said David Hooper, MD, professor of medicine, Harvard University, and chief of Infection Control, associate chief, Division of Infectious Diseases, Massachusetts General Hospital.