Oritavancin Granted FDA Approval for Treatment of Acute Bacterial Skin and Skin Structure Infections

Officials from the FDA have approved oritavancin (Kimyrsa, Melinta Therapeutics) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI).

Eligible ABSSSI for the treatment are caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). It is a lipoglycopeptide antibiotic that delivers a complete course of therapy in a 1 hour, 1200 mg infusion.

ABSSSI affects approximately 14 million patients in the United States each year, according to a press release, and are responsible for more than 3 million visits to emergency departments (EDs). They also present a significant cost to the health care system, as the eighth most common cause of ED hospital admissions and costing US hospitals $4 billion each year. Hospitalized patients have an average 4.1-day length of stay, according to the press release.

“Kimyrsa is an important new treatment option that will provide clinicians with additional flexibility to treat ABSSSI patients in multiple care settings, without the need for hospitalization,” said Andrew Dold, DO, an infectious disease specialist, in the press release. “Single-dose, long-acting antibiotics, such as Kimyrsa, may be especially beneficial for patients who lack the support or resources to adhere to multiple intravenous administrations.”

The efficacy and safety of oritavancin is based on the SOLO clinical trials, which investigated Orbactiv. The trials evaluated a single 1200 mg intravenous dose of oritavancin against twice-daily vancomycin for the treatment of ABSSSI in 1987 adults. They also assessed one of the largest subsets of documented MRSA infection, with 405 patients, according to the press release.

The trials found that the single 1200 mg infusion of oritavancin was as effective as 7-to-10 days of twice-daily vancomycin for the primary and secondary endpoints. The FDA approval of Kimyrsa is based on the results of an open-label, multi-center, pharmacokinetics study, which compared Kimyrsa administered over 1 hour to Orbactiv administered over 3 hours.

“Kimyrsa was shown to be comparable to Orbactiv with a favorable safety profile,” said lead investigator Michael Waters, MD, in the press release. “I’m pleased that these outcomes support the approval of Kimyrsa to provide oritavancin with a shorter infusion time and lower infusion volume. With these features, Kimyrsa can further enhance the treatment experience for the patient and efficiency of administration in clinical practice.

REFERENCE

Melinta Therapeutics Announces FDA Approval of Kimyrsa (Oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) [news release]. Melinta Therapeutics; March 15, 2021. https://melinta.com/melinta-therapeutics-announces-fda-approval-of-kimyrsa-oritavancin-for-the-treatment-of-adult-patients-with-acute-bacterial-skin-and-skin-structure-infections-absssi/. Accessed March 16, 2021.