New antibiotic for serious skin infection gets FDA approval
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The US Food and Drug Administration (FDA) on Friday, approved new antibiotic called delafloxacin to treat serious and acute bacterial skin infections, including one which is mostly tough to beat.
The drug, Baxdela or delafloxacin is developed by Melinta Therapeutics. It is intended to treat skin and skin structure infections caused by a variety of bacteria, plus methicillin-resistant staphylococcus aureus, or MRSA.
Baxdela belongs to a group of broad-spectrum antibiotics recognized as fluoroquinolones, which are generally given by infusion; however Baxdela can be given both,in oral form as well as by infusion.
Melinta approximates that around half of the 3 million patients hospitalized for acute skin infections get two drugs, generally vancomycin and a gram-negative drug, before a lab test to determine whether the bacteria isgram-negative or gram-positive.
The FDA found out that delafloxacin was safe and effectivecompared to an intravenous combination of vancomycin plus aztreonam. The result was based on two clinical trials involving roughly 1500 people with acute bacterial skin and skin structure infections(ABSSSIs).
Melinta's chief executive, Dr. Eugene Sun 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 further said.
The FDA had entitled delafloxacin as a qualified infectious-disease product, giving it to an expedited review.