Welcome to HCPFIVE, your go-to roundup for the latest healthcare news and breakthroughs is specifically curated for busy health professionals.
Each week, we highlight five important developments or headlines from healthcare that you need to know. Whether it's cutting edge treatment, regulatory updates, or innovations that will shape the future of medicine. This week's top story focused on oral weight loss drugs that achieve three key decisions from the US Food and Drug Administration (FDA), including weight loss of nearly 16%, oral inhibitors to lower blood pressure in uncontrolled hypertension, and a new target goal date for ketamine.
Using HCPFIVE gives you important points to provide information and stay in front of the curve. You can easily dive into the top stories of the week of March 9th, 2025.
Are you interested in oncology news? Check out oncfive from the sisters' publication Onclive.
Cagrisema brings nearly 16% weight loss in phase 3 redefine 2 trials
With a fixed dose combination of CagrilIntide 2.4 mg and Semaglutide 2.4 mg, Cagrisema was superior to placebo in adults with obese or overweight, type 2 diabetes (T2D), but lacked for the expected weight loss of 25% or more for Novo Nordisk. In the Phase 3 Redefine 2 trial, Cagrisema achieved nearly 16% weight loss compared to 3% for placebo when all individuals adhered to treatment.
Lorundrostat significantly lowers blood pressure in major hypertension tests
The efficacy and safety of critical phase 3 firing-HTN and phase 2 advanced HTN trials demonstrated the promise of Lorundrostat treatment for uncontrolled hypertension (UHTN) or resistant hypertension (RHTN). Both studies showed that the mineral therapeutic oraldosterone synthase inhibitor achieved a statistically significant reduction in systolic blood pressure while maintaining favorable safety and tolerability.
Pharmather will receive Ketamine's new FDA goal date in early June
In the release, Pharmather announced the receipt of a new FDA target goal date for ketamine to treat anesthesia, sedation, pain, mental health and neurological signs. In its Amendment Authorization (AAL), the FDA has confirmed that the drug meets the criteria for priority review and has set a new target date for June 4, 2025.
FDA designates XLRS' fast tracking designation for ATSN-20101 gene therapy
The FDA has granted the designation of high-speed tracks to ATSN-20101 for the treatment of X-conjugated retinosis (XLRS) following the designation of orphans and rare childhood diseases. This new designation allows Atsena Therapeutics to receive priority reviews of institutions for new gene therapy if relevant criteria are met.
FDA approves first exchangeable biosimilar for omalizumab
The FDA approved omalizumab-Gec (Omliclo) as the first replaceable biosimilar of omalizumab (xolair) to mark the first respiratory biosimilar for the treatment of moderate to severe persistent asthma. ur measles (CSU). Biosimilars were approved for subcutaneous doses of 75 mg/0.5 mL and 150 mg/mL.
