MORRISTOWN, N.J.--(BUSINESS WIRE)--Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced the commercial launch of KIMYRSA™ (oritavancin), a lipoglycopeptide antibiotic that delivers a complete course of therapy for acute bacterial skin and skin structure infections (ABSSSI) in a single, one hour, 1,200 mg infusion. The U.S. Food and Drug Administration approved KIMYRSA on March 12, 2021, for the treatment of adult patients with ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
“Melinta is focused on expanding our portfolio to provide innovative therapies to patients with an unmet need, and the launch of KIMYRSA demonstrates this commitment,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “Now, physicians and patients will have a new, one-hour, single-dose alternative to the current standard of multi-dose regimens for ABSSSI. Our vision is that all patients who need our therapies will be able to receive them and we believe this important new medicine will provide patients with more flexibility and accessibility in ABSSSI treatment outside of the hospital setting.”
ABSSSIs affect approximately 14 million patients in the U.S. each year, are responsible for more than 3 million visits to the emergency room annually, and represent the 8th most common cause of emergency department hospital admissions.1,2 ABSSSIs cost U.S. hospitals $4 billion each year, with a 4.0-day average length of stay for a hospitalized ABSSSI patient.2
“KIMYRSA is a direct response to the requests of the medical community to provide an oritavancin product with a shorter infusion time, additional diluent options, and lower infusion volume,” said John Harlow, Chief Commercial Officer. “As the second product in the oritavancin franchise, our commercial team has deep experience serving this market and we are excited to have begun introducing this new therapy to our customers.”
For more information about KIMYRSA, visit www.kimyrsa.com.
About KIMYRSA™ (oritavancin)
KIMYRSA™ (oritavancin) is a single-dose, long-acting lipoglycopeptide antibiotic with rapid bactericidal activity for the treatment of adult patients with ABSSSI caused by designated susceptible 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® (oritavancin) 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.
KIMYRSA™ and ORBACTIV® INDICATION AND USAGE
Both KIMYRSA™ and, ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by 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, dilution 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 KIMYRSA were hypersensitivity, pruritis, chills and pyrexia.
About Melinta Therapeutics
Melinta Therapeutics provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. 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.
- 2018 Data from HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. https://hcupnet.ahrq.gov/