FDA Approves Baxdela for Skin Infections

Melinta Therapeutics announced the FDA had approved Baxdela, a drug intended to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Because Baxdela is a fluoroquinolone, it is also effective in treating MRSA (methicillin-resistant Staphylococcus aureus) and against other gram-positive or gram-negative pathogens.

“Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine,” David Hooper, MD, professor of medicine aqt Harvard University, and chief of Infection Control and associate chief in the Division of Infectious Diseases at Massachusetts General Hospital, said in a statement. “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.”

Baxdela was involved in two phase 3 studies with ABSSSI patients, demonstrating that Baxdela as an intravenous (IV) or oral monotherapy, is not inferior to vancomycin and aztreonam at the FDA endpoint of early clinical response. The 450 mg tablet is determined to be equivalent and to the 300 mg IV dose.

“The approval of Baxdela demonstrates FDA’s commitment to making new and effective antibiotics available to address unmet needs for hospitalized ABSSSI patients,” said Eugene Sun, MD, CEO of Melinta.

Baxdela also did not show potential for QT prolongation or phototoxicity. The clinical studies did not show any signs of negative effects on liver and kidney function, or glucose regulation.

“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,” said Sun. “Baxdela provides a treatment option for adult patients with ABSSSI based on its coverage spectrum, IV and oral dosing flexibility, efficacy and safety profile.”