Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, November 1, to Friday, November 8, 2024), and click on each link to read and watch anything you may have missed.

FDA accepts donidalorsen NDA for prophylactic hereditary angioedema

The acceptance of a New Drug Application (NDA) has been issued by the FDA for Ionis Pharmaceuticals' donidalorsen, an investigational RNA-targeted prophylaxis medicine to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

According to a press release from Ionis, the federal agency has set a Prescription Drug User Fee Act date of August 21, 2025.
Click here for full pipeline details.

Pediatric ADHD trends and using clonidine hydrochloride as another treatment tool

In this Contemporary Pediatrics video interview, Rakesh Jain, MD, MPH, clinical professor, psychiatry, Texas Tech University School of Medicine, discussed the now-available, FDA-approved clonidine hydrochloride (ONYDA XR; Tris Pharma), and how having this tool can go a long way to helping more pediatric patients with attention-deficit/hyperactivity disorder (ADHD).

This extended-release, liquid formulation is a non-stimulant treatment option that expands the toolkit for managing this increasingly prevalent condition.

Click here to watch.

FDA pushes PDUFA date of tapinarof cream, 1% for atopic dermatitis to 2025

The Prescription Drug User Fee Act (PDUFA) date for Dermavant's (now part of Organon) tapinarof cream, 1% (VTAMA) to treat atopic dermatitis in adults and children aged 2 years and up, has been extended by 3 months. The new target action date has been set for March 12, 2025.

Topline data for the topical, steroid-free, aryl hydrocarbon receptor from the ADORING 3 LTE was presented at the 44th Annual Fall Clinical Dermatology Conference in October 2024.

Click here for full details.

MenACWY program associated with reduced invasive meningococcal disease among adolescents

Results from a decision analytical model of the entire population of the United States from 2001 to 2021 revealed the MenACWY vaccination program in the country was associated with a reduced burden of meningococcal disease. Results demonstrated that incidence of invasive meningococcal disease among individuals aged 11 to 23 years would have been at least 59% higher without vaccination.

Click here for full study details.