Weekly review: New FDA approvals for T2D, pJIA, and more


Get caught up with our journal! Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.

Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, June 10, to Friday, June 17, 2024), and click on each link to read and watch anything you may have missed.

1. New roflumilast cream 0.15% data demonstrate improvements in AD symptoms at 56 weeks

A recent study published in Frontiers found a causal relationship between childhood asthma (CA) and dietary intake of sugars, fats, and serum levels of magnesium and vitamin D. Using Mendelian Randomization (MR) methodology, researchers assessed associations between CA and various dietary factors, including carbohydrates, proteins, fats, sugars, serum antioxidants, minerals, and vitamins. The study revealed that sugar intake was inversely correlated with CA risk (OR: 0.71, 95% CI: 0.55-0.91, P: 0.01), while higher levels of serum magnesium (OR: 1.63, 95% CI: 1.06-2.53, P: 0.03), fats (OR: 1.44, 95% CI: 1.06-1.95, P: 0.02), and serum vitamin D (OR: 1.14, 95% CI: 1.04-1.25, P: 0.02) were linked to an increased CA risk.

Click here for the full article.

2.) FDA approves sarilumab to treat active polyarticular juvenile idiopathic arthritis

Sarilumab (Kevzara; Regeneron and Sanofi) has been FDA-approved for treating active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing 63 kg (138.891 lbs) or more. pJIA can cause joint pain, stiffness, swelling, and potentially permanent joint damage. George D. Yancopoulos, MD, PhD, from Regeneron highlighted the significance of this new treatment option for affected children and their families. The approval was based on studies in adults with rheumatoid arthritis and a phase 2, 12-week dose-finding trial (NCT02776735) involving 42 pediatric patients. The study showed sarilumab's efficacy and safety, with no new adverse reactions compared to the adult population. Common adverse reactions included nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema.

Click here for full FDA approval details.

3.) FDA approves dapagliflozin to improve glycemic control in pediatric T2D patients

The FDA has approved dapagliflozin (Farxiga; AstraZeneca) for pediatric patients aged 10 years and older with type 2 diabetes (T2D) to improve glycemic control. This first-in-class, once-daily, oral SGLT2 inhibitor was approved based on the pediatric T2NOW phase 3 trial (NCT03199053), which showed significant A1c reduction in patients treated with dapagliflozin compared to placebo. The 26-week trial with a 26-week extension involved patients aged 10 to 17 with uncontrolled T2D on metformin, insulin, or both.

The trial met all primary and secondary endpoints, highlighting dapagliflozin's efficacy and safety in pediatric T2D management.

Click here for full FDA approval details.

4.) Experts highlight common waterborne illnesses, preventive tips for summer

In this Q+A interview, Tina Tan, MD, FAAP, FIDSA, FPIDS, and Shreya Doshi, MBBS, FAAP, highlight common waterborne illnesses as summer ramps up and children, adolescents, and teenagers are in the water more frequently compared to other times throughout the year. Tan is the editor in chief of Contemporary Pediatrics, professor of pediatrics at the Feinberg School of Medicine at Northwestern University, and is a pediatric infectious diseases attending at Ann & Robert H. Lurie Children’s Hospital in Chicago, Illinois. Doshi is a board-certified pediatrician and infectious diseases fellow at Children’s National Hospital in Washington DC.

Tan and Doshi provide:

- Reminders for pediatric providers

- Common skin infections associated with water

- Practical advise for families

Click here for full commentary and recommendations.

5.) Top tips for water safety

In this article, view the CDC's guidelines for keeping the pool safe and healthy, perfect tips to pass along to parents during the summer season. This article features:

- Tips to prevent drowning

- Tips to prevent pool chemical injuries

- Recommendations to kill germs in the pool

- Safe swimming

Click here for tips. Think these tips would help parents? Print a copy and use as a handout.

Trending article on Contemporary Pediatrics:

This article will detail how a recently activated code, G2211, will increase practice revenue and provider compensation. It may take some time, however, for insurance carriers to begin reimbursing for this add-on code, so pediatricians should be prepared to challenge rejected claims.

Click here for the full article.

FDA committee unanimously votes in favor of updated COVID vaccine

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 16-0 to recommend a monovalent vaccine from the omicron JN.1 lineage for this fall, aligning with circulating strains . The FDA will consider this recommendation before making a final decision on the updated vaccine composition.

In May 2024, the CDC reported JN.1 made up 8.4% of cases, KP.2 28.5%, and KP.3 12.7%.

Click here for more on the FDA's Vaccine and Related Biological Products Advisory Committee's (VRBPAC) recommendation.

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