FDA approves single-dose infusion to treat ABSSSI in pediatric patients
The FDA approved Dalvance (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Dalvance is the first single-dose option administered as an I.V. infusion for the treatment of ABSSSI caused by designated susceptible gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis (vancomycin-susceptible isolates).
Dalvance is a single-dose regimen based on age and weight in pediatric patients and is administered over 30 minutes.
Nucala approved as add-on maintenance treatment for chronic rhinosinusitis
The FDA approved Nucala (mepolizumab) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years of age and older with inadequate response to nasal corticosteroids. Nucala is already approved for the treatment of eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype.
The approval was based on a study in 400 adults with CRSwNP who all had a history of prior surgery and needed further surgery due to severe symptoms and increased polyp size. After 1 year, patients treated with Nucala had a significant improvement in bilateral nasal polyp score at week 52 and nasal obstruction visual analogue scale score from weeks 49 to 52. The proportion of patients who had surgery was significantly reduced by 57% in the group treated with Nucala versus placebo; Nucala treatment was also associated with significant improvement in loss of smell and with a reduced need for systemic corticosteroids.
Zegalogue injection now available for severe hypoglycemia
Zealand Pharma's Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes 6 years of age and older is now available. Zegalogue is a glucagon analogue supplied in a ready-to-use solution for subcutaneous administration. Each device provides a single dose of Zegalogue and cannot be reused.
In phase 3 trials in adult and pediatric patients with type 1 diabetes mellitus, Zegalogue was associated with a shorter median time to plasma glucose recovery compared with placebo.
The most common adverse reactions associated with Zegalogue include nausea, vomiting, headache, diarrhea, and injection-site pain. The drug is contraindicated in patients with pheochromocytoma and in those with insulinoma. Zegalogue should be stored in a refrigerator but can be kept at room temperature for up to 1 year.
Drug now indicated for younger patients with chronic hepatitis C
Gilead's Epclusa (sofosbuvir/velpatasvir) is now approved for treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with ribavirin in those with decompensated cirrhosis. Epclusa was previously approved only for patients 6 years of age and older.
The FDA also approved an oral pellet formulation of Epclusa (200 mg/50 mg and 150 mg/37.5 mg) for use in younger patients who have difficulty swallowing tablets. The oral pellets can be taken directly via the mouth or sprinkled on nonacidic soft food. The most common adverse reactions associated with Epclusa in younger patients include vomiting and spitting up the drug.