The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.
Melinta Therapeutics has launched Kimyrsa (oritavancin), a lipoglycopeptide antibiotic to treat acute bacterial skin and skin structure infections (ABSSSI) in a single, one hour, 1,200 mg infusion.
The FDA had approved Kimyrsa in March 2021, for the treatment of adult patients with ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
“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,” John Harlow, chief commercial officer of Melinta said in a statement.
The company already markets Orbactiv, a oritavancin that was approved in 2014 and has a three-hour infusion time.
ABSSSIs affect about 14 million patients in the United States each year and are responsible for more than 3 million visits to the emergency room annually, according to press release issued by Melinta.
An increase in MRSA skin infections has been a major contributor to the U.S. burden of skin infections. In one study, investigators found that the rate of clinically-diagnosed skin and soft tissue infections was 496 per 10,000 person-years, with MRSA infections being 46% of the Staphylococcus aureus infections that were cultured.
Treatment of ABSSSI is not straightforward, and poor outcomes are characterized by spreading infection, bacteremia, septic shock, osteomyelitis, recurrence, prolonged hospitalization, or death.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
Joseph Zabinski Advocates for Patient Trust in AI Adoption in Dermatology Care
April 18th 2024Joseph Zabinski, PhD, MEM, vice president, head of commercial strategy and AI, OM1, chatted with MHE editors on the significance of patient acceptance in AI adoption in healthcare, overall and in the dermatology space, stressing trust and transparency.
Read More