The U.S. Food and Drug Administration (FDA) approved of Melinta Therapeutics’ antibiotic Kimyrsa (oritavancin) for adults diagnosed with acute bacterial skin and skin structure infections (ABSSSI). Caused by susceptible isolates of designated Gram-positive microorganisms, ABSSSI infects approximately 14 million people in the US annually and accounts for more than 3 million ER (emergency room) visits. The approval comes after FDA review of clinical trials with nearly 2,000 patients that demonstrated the drug’s efficacy to be the same as vancomycin in treating MRSA.
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