Melinta Therapeutics can now add another antibiotic to its portfolio after the FDA on Monday approved the company’s infused treatment for serious skin infections such as MRSA.
Approval of oritavancin, which will be marketed under the name Kimyrsa, covers the treatment of acute bacterial skin and skin structure infections (ABSSSI). The New Haven, Connecticut-based company already sells another oritavancin-based product, Orbactiv. But Kimyrsa will offer the prospect of a single, one-hour infusion compared to Orbactiv, which is infused over the course of three hours. Approved in 2014, Orbactiv was developed as an alternative to vancomycin, an antibiotic that is infused twice daily for seven to 10 days.
Melinta used data from Orbactiv’s clinical trials to establish the safety and efficacy of Kimyrsa. Those studies in nearly 2,000 patients showed that the single infusion of oritavancin was as effective as vancomycin in treating patients with methicillin-resistant Staphylococcus aureus, or MRSA. The most common adverse events in the Orbactiv clinical studies were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. FDA approval of Kimyrsa was based on the results of an open-label study that compared that drug to Orbactiv. The results found that the safety and efficacy of Kimyrsa was comparable to Orbactiv.
ABSSSI affects an estimated 14 million patients in the U.S. each year, and these infections lead to about 3 million emergency room visits each year, according to the Agency for Healthcare Research and Quality. These infections can also lead to hospitalization; treating these infections costs U.S. hospital an estimated $4 billion annually.
Both Orbactiv and Kimyrsa are approved for treating adults with ABSSSI caused by so-called Gram-positive microorganisms, which include Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis. To reduce the development of drug-resistant bacteria, Orbactiv’s label says it should only be used “to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.”
Orbactiv was originally developed by The Medicines Company (which was acquired by Novartis last year in a $9.7 billion deal). Melinta had acquired Orbactiv and two other Medicines Company antibiotics in a 2018 deal. But like many antibiotics biotechs, Melinta had a tough time growing revenue for lineup of products that clinicians are instructed to use sparingly in order to minimize drug resistance. The company filed for Chapter 11 bankruptcy protection in 2019 and found no bidders for its assets. Deerfield Management, a creditor, took over those assets a little more than a year ago.
Kimyrsa gives Melinta another product to contribute to its sales after losing a bidding war last year for Tetraphase Pharmaceuticals. Melinta had reached a $39 million deal to buy Tetraphase and its FDA-approved antibiotic for complicated intra-abdominal infections. But La Jolla Pharmaceuticals topped that bid by offering $4 million more.
In a prepared statement, Melinta President and CEO Christine Ann Miller said that the company expects Kimyrsa will become available this summer.
