I.V. antibiotic approved for acute bacterial skin/skin structure infections
The FDA approved Kimyrsa (oritavancin) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible isolates of designated Gram-positive microorganisms. Kimyrsa is a single-dose, long-acting lipoglycopeptide antibiotic indicated for the treatment of 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)
* Enterococcus faecalis (vancomycin-susceptible isolates only).
The safety and efficacy of oritavancin were supported by data from trials that compared a single dose of oritavancin 1,200 mg I.V. to vancomycin (1 g or 15 mg/kg I.V. twice daily for 7 to 10 days). Oritavancin was as effective as vancomycin for the studies' primary and secondary end points.
The most common adverse reactions of oritavancin reported in the clinical trials include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
Kimyrsa is expected to be available in the summer of 2021 and is a product of Melinta Therapeutics.
FDA approves drug for severe hypoglycemia
The FDA approved Zegalogue (dasiglucagon) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes 6 years of age and older. The glucagon analogue is formulated in a ready-to-use aqueous solution for subcutaneous administration. Zegalogue is supplied as a 0.6 mg/0.6 mL single-dose autoinjector or prefilled syringe for subcutaneous injection.
The most common adverse reactions reported in studies were nausea, vomiting, headache, diarrhea, and injection site pain.
Zegalogue is a product of Zealand Pharma.
FDA expands age indication of Flucelvax Quadrivalent flu vaccine
The FDA approved the use of Flucelvax Quadrivalent influenza vaccine for individuals 2 years of age and older. Flucelvax Quadrivalent was previously approved for use in individuals 4 years of age and older. The vaccine is a product of Seqirus.
Flucelvax Quadrivalent is a cell-based quadrivalent vaccine, according to the manufacturer. The cell-based influenza vaccine manufacturing process is an alternative to traditional egg-based vaccine manufacturing and is designed to help avoid egg-adapted mutations. Cell-based manufacturing may result in vaccine virus strains that are more closely matched to those selected by the World Health Organization.
Clinical trial results showed that Flucelvax Quadrivalent was effective and produced a sufficient immune response against influenza in children and adolescents ages 2 through 17 over three influenza seasons in the Southern and Northern Hemispheres compared with a noninfluenza comparator. Flucelvax Quadrivalent will be available as a 0.5 mL I.M. vaccine per dose for the 2021-2022 US influenza season.
FDA approves new once-daily ADHD treatment
The FDA approved Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules for oral use (CII) for the once-daily treatment of attention-deficit hyperactivity disorder (ADHD) in patients 6 years of age and older. Azstarys consists of serdexmethylphenidate, a prodrug of dexmethylphenidate, coformulated with immediate-release dexmethylphenidate.
Azstarys is available in capsule form and should be taken orally once daily in the morning; it is a product of KemPharm and is expected to be available in the second half of 2021.