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Stay updated with the latest healthcare breakthroughs, including an FDA approval and new clinical trial data, in this week's essential news roundup.
Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.
Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approval of fremanezumab (Ajovy) for the preventive treatment of episodic migraine in children and adolescents 6-17 years of age weighing ≥ 99 lbs, trial data for orforglipron in obesity/overweight and oral berotralstat in hereditary angioedema (HAE), insight into different doses of aflibercept for diabetic macular edema (DME), and IBS in America survey results from the American Gastroenterological Association.
With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of August 03, 2025—let’s jump in!
On August 6, 2025, the FDA approved fremanezumab (Ajovy) for the preventive treatment of episodic migraine in children and adolescents 6-17 years of age who weigh ≥ 99 pounds (45 kg), making it the first calcitonin gene-related peptide antagonist approved for preventive treatment of episodic migraine in pediatric patients.
The decision expands upon fremanezumab’s previous indication for adults with migraine, granted in 2018, and was based on positive data from the phase 3 SPACE trial showing participants on fremanezumab had significantly reduced monthly migraine days and monthly headache days compared to placebo.
On August 7, 2025, Eli Lilly and Company announced positive topline results from the phase 3 ATTAIN-1 trial evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3127 adults with obesity, or overweight with a weight-related medical problem and without diabetes. At 72 weeks, all 3 doses of orforglipron met the primary endpoint and all key secondary endpoints compared to placebo, delivering clinically meaningful weight loss as an adjunct to a healthy diet and physical activity.
Interim data from the APeX-P trial of oral berotralstat in children 2-11 years of age with HAE highlight the small-molecule plasma kallikrein inhibitor’s safety and efficacy in this patient population.
Aflibercept 8mg is noninferior to aflibercept 2mg for best-corrected visual acuity in patients with DME secondary to retinal vein occlusion, according to findings from the ongoing, 64-week, randomized, double-blind, active-controlled phase 3 QUASAR study. Of note, patients assigned to aflibercept 8mg achieved BCVA gains with fewer injections compared to aflibercept 2mg over 36 weeks.
Findings from a new survey suggest irritable bowel syndrome (IBS) symptoms continue to significantly impact patients’ daily lives and productivity despite recent advances in public awareness and expanded treatment options. Released by the American Gastroenterological Association in partnership with The Harris Poll, findings from the IBS in America survey shed light on persistent challenges faced by patients with IBS as well as shifts in patient experiences, health care provider perceptions, and the treatment landscape for IBS from a similar study conducted in 2015.