FDA approves new antibiotic, Baxdela to treat serious skin infections

The U.S. Food and Drug Administration on Monday approved a new treatment for patients with acute bacterial skin infections, made by privately held Melinta Therapeutics.

The drug, Baxdela, or delafloxacin, is designed to treat skin and skin structure infections caused by a range of bacteria, including methicillin-resistant staphylococcus aureus, or MRSA.

Baxdela belongs to a common class of broad-spectrum antibiotics known as fluoroquinolones, which are typically given by infusion. Baxdela can be given both by infusion and in oral form.

The drug was shown in clinical trials to be no less effective than a combination of vancomycin, the go-to drug for serious gram-positive infections, and aztreonam, a drug to treat gram-negative infections, both of which are available in generic form.

Melinta estimates that about 40 percent of the 3 million patients hospitalized for serious skin infections receive two drugs, typically vancomycin and a gram-negative drug, rather than waiting for a lab test to determine whether the bug is gram-positive or gram-negative.

Dr. Eugene Sun, Melinta's chief executive, said the company plans to price the drug "competitively with other agents in the same space."

"We are acutely aware of the stresses on the (healthcare) system," he said.

(Reporting by Toni Clarke in Washington; Editing by James Dalgleish)