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 a trio of US Food and Drug Administration approvals for clesrovimab (Enflonsia) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants, glecaprevir/pibrentasvir (Mavyret) for acute hepatitis C virus (HCV), and prednisolone acetate ophthalmic suspension for steroid-responsive ocular inflammation, as well as a Fast Track Designation for mavorixafor for the treatment of chronic neutropenia and phase 3 data for iptacopan in paroxysmal nocturnal hemoglobinuria (PNH).
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 June 8, 2025—let’s jump in!
Interested in oncology news? Check out The OncFive, from our sister publication OncLive.
FDA Approves Clesrovimab RSV Immunization for Newborns and Infants
One June 9, 2025, the FDA approved clesrovimab, under the name Enflonsia, for preventing RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. The decision was based on data from the pivotal phase 2b/3 CLEVER trial evaluating a single dose of clesrovimab administered to preterm and full-term infants (from birth to 1 year of age), as well as the phase 3 SMART trial evaluating the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease.
FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV
On June 11, 2025, the FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With this decision, glecaprevir/pibrentasvir is now approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis. Of note, the decision makes glecaprevir/pibrentasvir the first and only DAA therapy approved to treat patients with acute HCV in 8 weeks with a 96% cure rate.
FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation
On June 12, 2025, the FDA approved prednisolone acetate ophthalmic suspension, USP 1%, a sterile, topical anti-inflammatory agent, for the treatment of steroid-responsive ocular inflammation. It is a self-administered eye drop intended for use 2-4 times daily. During the first 24 hours of treatment, this frequency may be increased if necessary.
In addition to the approval, parent company Amneal Pharmaceuticals, Inc. announced a planned launch of the product for the third quarter of 2025.
FDA Grants Fast Track Designation to Mavorixafor for Chronic Neutropenia
On June 10, 2025, the FDA granted Fast Track designation to mavorixafor, an oral CXCR4 antagonist, for the treatment of chronic neutropenia. The agent is currently being examined in the ongoing phase 3 4WARD trial and was previously approved in 2024 for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis) in patients ≥12 years of age.
Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial
Positive results from APPULSE-PNH highlight the safety and efficacy of twice-daily oral monotherapy iptacopan (Fabhalta) in adults with PNH with hemoglobin (Hb) levels ≥10 g/dL who switched from the anti-C5 therapies eculizumab or ravulizumab.
Findings showed the vast majority of patients (92.7%) achieved Hb ≥12 g/dL, and none required transfusion during the study. Additionally, many patients treated with iptacopan also reported clinically meaningful improvements in fatigue. Novartis also noted maintenance of intravascular hemolysis control and resolved extravascular hemolysis control, demonstrated by lactate dehydrogenase levels and a reduction in absolute reticulocyte count. Iptacopan was well-tolerated and exhibited no new safety signals.
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