MORRISTOWN, N.J.--(BUSINESS WIRE)--Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, today announced that the U.S. Food and Drug Administration (FDA) has approved KIMYRSA™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). KIMYRSA is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion.
“The approval of KIMYRSA demonstrates Melinta’s commitment to provide innovative therapies to patients with acute and life-threatening illnesses,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time. We believe that with the approval of KIMYRSA and product availability this summer, physicians and patients will now have a compelling new one-dose alternative to the current standard of multi-dose regimens for ABSSSI.”
ABSSSI affect approximately 14 million patients in the U.S. each year, are responsible for over 3 million visits to the Emergency Room annually and represent the 8th most common cause of Emergency Department hospital admissions1,2. ABSSSI cost U.S. hospitals $4 billion each year, with a 4.1-day average length of stay for hospitalized ABSSSI patients.2
“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, D.O., member of a private infectious disease practice covering the Greater Atlanta Region. “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 KIMYRSA were established in the SOLO clinical trials with another oritavancin product, ORBACTIV®. The SOLO trials were randomized, double-blind, multicenter studies that evaluated a single 1,200 mg IV dose of oritavancin against twice-daily vancomycin for the treatment of ABSSSI in 1,987 adult patients and assessed one of the largest subsets of documented MRSA infection (405 patients). These trials demonstrated that 1,200 mg one-dose IV oritavancin infusion was as effective as 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg) for the primary and secondary endpoints. KIMYRSA approval is based on the results of an open-label, multi-center, pharmacokinetics study, which compared KIMYRSA administered over 1 hour (N=50) to ORBACTIV administered over 3 hours (N=52) for the treatment of adult patients with ABSSSI.
Michael Waters, M.D. and lead investigator in the PK clinical trial stated, “KIMYRSA was shown to be comparable to ORBACTIV with a favorable safety profile. 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.”
Melinta is planning to launch KIMYRSA in summer 2021.
About KIMYRSA™ (oritavancin)
KIMYRSATM (oritavancin) is a single-dose, long-acting lipoglycopeptide antibiotic with rapid bactericidal activity for the treatment of adult patients with ABSSI caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
KIMYRSA is the first oritavancin product that is infused over one-hour, prepared from one 1,200 mg vial, and has compatibility with both 0.9% sodium chloride injection (NS) and 5% dextrose in sterile water (D5W). As an oritavancin product, KIMYRSA has three bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity.
KIMYRSA approval is based on the results of a pharmacokinetics (PK) study that compared KIMYRSA administered over 1 hour (N=50) to ORBACTIV® administered over 3 hours (N=52) for the treatment of adult patients with ABSSSI. The efficacy and safety of KIMYRSA were established in the SOLO clinical trials with another oritavancin product, ORBACTIV. The SOLO trials were randomized, double-blind, multicenter studies that evaluated a single 1,200 mg IV dose of oritavancin for the treatment of ABSSSI in 1,987 adult patients. These trials demonstrated that 1,200 mg one-dose IV oritavancin infusion was as effective as 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg) for the primary and secondary endpoints. The most common adverse reactions in patients treated with oritavancin were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in ≥2 patients receiving KIMYRSA in the PK study were hypersensitivity, pruritus, chills and pyrexia.
KIMYRSATM and ORBACTIV® INDICATION AND USAGE
Both KIMYRSATM and, ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of oritavancin and other antibacterial drugs, oritavancin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
KIMYRSA and ORBACTIV are not approved for combination use and have differences in dose strength, duration of infusion, and preparation instructions, including reconstitution and dilution instructions and compatible diluents. Please see the full Prescribing Information available at www.melinta.com.
IMPORTANT SAFETY INFORMATION
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after oritavancin administration.
Oritavancin products are contraindicated in patients with known hypersensitivity to oritavancin.
Warnings and Precautions
Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours.
Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.
Infusion Related Reactions: Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products, including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.
Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT and INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving oritavancin products and warfarin.
Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
Prescribing oritavancin products in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in >2 patients receiving KIMYRSATM were hypersensitivity, pruritis, chills and pyrexia.
About Melinta Therapeutics
Melinta Therapeutics, LLC is the largest pure-play antibiotics company, dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. There are currently five commercial-stage antibiotics in the Melinta portfolio: Baxdela® (delafloxacin), KimyrsaTM (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). This portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
- Hersh AL, Chambers, HF, et al; National Trends in Ambulatory Visist and Antibiotic Prescribing for Skin and Soft-Tissue Infections. Arch Intern Med. 2008;168(14):1585-1591.
2017 Data from HCUPnet, Healthcare Cost and Utilization Project (HCUP).
Agency for Healthcare Research and Quality, Rockville, MD. http://hcupnet.ahrq.gov/