This week, check out our coverage on 2 antibiotic FDA approvals, and clinicians weigh in on the ACIP recommendations on the hepatitis B virus (HBV) vaccine.
the FDA approved Innoviva Specialty Therapeutics’ zoliflodacin (Nuzolvence), a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. This approval was based from data of a phase 3 trial, which was published in
The FDA approved GSK’s antibiotic, gepotidacin, for the treatment of uncomplicated urogenital gonorrhea in patients 12 years or older (weighing ≥ 45 kg [99.2 lb]). This approval was based from data of the EAGLE-1 phase 3 trial results, which were published in The Lancet, showing that gepotidacin (oral, 2 doses of 3000 mg) was noninferior, with a 92.6% (187 of 202; 95% CI, 88.0%-95.8%) success rate at urogenital site when compared with a 91.2% (186 of 204; 95% CI, 86.4%-94.7%) success rate for intramuscular ceftriaxone (500 mg) plus oral azithromycin (1000 mg) combined therapy.1
Contagion spoke to GSK VP Head of Infectious Disease Research David Payne, PhD, who offered more information about the study including its safety profile, efficacy results, and the importance of the lack of bacterial persistence at the urogenital site.
Last week, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) had a 2-day meeting to discuss the birth dose of the hepatitis B vaccine. Infectious disease pediatrician Sharon Nachman, MD, talks about how the new recommendations will defer immunization, leading to potential negative impacts on long-term public health.
Robert Hopkins Jr, MD, medical director of the National Foundation for Infectious Diseases, discusses the changes in the new vaccine recommendations and what potential serious consequences may be seen as a result.
