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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, June 16, to Friday, June 20, 2025), and click on each link to read and watch anything you may have missed.
FDA approves twice-yearly lenacapavir as PrEP for HIV in adolescents, adults
On June 18, 2025, the FDA approved lenacapavir (Yeztugo; Gilead Sciences), a subcutaneous HIV-1 capsid inhibitor, as the first and only twice-yearly pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg (77 lbs). The approval marks a milestone in HIV prevention, offering a long-acting alternative to daily oral PrEP.
The decision was supported by positive results from the phase 3 PURPOSE 1 and PURPOSE 2 trials, in which lenacapavir demonstrated superior HIV prevention compared to daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF), with over 99.9% of participants remaining HIV negative across diverse populations. The extended dosing interval may help address challenges such as adherence and stigma, potentially improving uptake and persistence in at-risk populations.
Click here for more details and additional data.
FDA approves garadacimab-gxii to prevent HAE attacks in patients aged 12 years, older
On June 16, 2025, the FDA approved garadacimab-gxii (Andembry; CSL) for the prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older, making it the first factor XIIa-targeting monoclonal antibody approved for prophylactic use in this population.
Approval was based on the phase 3 VANGUARD trial, which demonstrated that once-monthly garadacimab-gxii significantly reduced HAE attacks by 86.5% compared to placebo, with a median attack rate reduction of over 99%. Interim data from an ongoing extension study supported its long-term safety and efficacy. CSL's first fully developed monoclonal antibody offers a new mechanism of action and monthly dosing convenience for patients with this rare, life-threatening disease.
Click here for full approval details, and other recent HAE news.
AAP updates guidance on contraception for adolescents
The American Academy of Pediatrics (AAP) released updated guidance in Pediatrics urging pediatricians to take a comprehensive, adolescent-centered approach to contraceptive care, replacing its 2014 policy.
The AAP now recommends developmentally appropriate contraceptive counseling that supports adolescent autonomy and equitable access to the full range of methods, including long-acting reversible contraception, hormonal options, barrier methods, and emergency contraception. The policy emphasizes the importance of confidential, one-on-one conversations regardless of parental presence, and supports expanding access through telehealth and school-based services. The updated statement also encourages pediatricians to integrate contraceptive counseling with broader reproductive health care, including STI screening and HPV vaccination.
Click here for additional details.
John Browning, MD, explains dermatological questions to ask, answer in primary care