The HCPFive: Top News for Healthcare Providers from the Week of 02/23

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 included the US Food and Drug Administration's (FDA) approval of an expanded indication for buprenorphine extended-release injection, Pfizer dropping a recently approved gene therapy, a pair of new regulatory applications, and phase 3 data from the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress.

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 February 23, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

Top News for Healthcare Providers from the Week of 02/23

1. FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

On February 24, 2025, Indivior announced the FDA approved a prior supplement submission for buprenorphine extended-release injection (SUBLOCADE) for opioid use disorder (OUD). The approval expands the injection site options and reduces induction time, allowing for faster treatment initiation. These updates aim to improve patient adherence and outcomes while maintaining the therapy’s established efficacy and safety profile.

2. Pfizer Drops Approved Hemophilia B Gene Therapy

On February 21, 2025, Pfizer announced it is discontinuing the development and commercialization of fidanacogene elaparvovec (Beqvez) for hemophilia B, less than a year after its FDA approval. The decision was attributed to limited market interest in gene therapies for hemophilia, with no patients having received the $3.5 million therapy commercially. This move follows Pfizer’s broader retreat from gene therapy, including halting other investigational programs for Duchenne muscular dystrophy and hemophilia A.

3. FDA Accepts Roflumilast Cream sNDA in Atopic Dermatitis for Ages 2-5 Years
On February 26, 2025, Arcutis Biotherapeutics announced the FDA accepted its sNDA for roflumilast cream 0.05% (Zoryve) for mild to moderate atopic dermatitis in children aged 2 to 5 years, with a PDUFA target action date of October 13, 2025. The application is supported by positive data from the phase 3 INTEGUMENT-PED trial, demonstrating significant efficacy and a favorable safety profile. If approved, roflumilast cream would offer a steroid-free, once-daily topical treatment option for young children with atopic dermatitis.

4. Phase 3 Data Supports Sebetralstat Efficacy for HAE Attacks Ahead of PDUFA Date

Findings from the phase 3 KONFIDENT and KONFIDENT-S trials presented at the 2025 AAAAI/WAO Joint Congress showed oral sebetralstat was rapidly administered and provided quick symptom relief in adolescents with hereditary angioedema-C1INH. The positive data support its potential approval as the first oral on-demand treatment for HAE. In September 2024, KalVista Pharmaceuticals announced the FDA accepted its NDA for sebetralstat for on-demand treatment of hereditary angioedema, with a PDUFA goal date of June 17, 2025.

5. FDA Accepts sNDA for Risperidone Extended-Release Injectable Suspension for Bipolar I Disorder

On February 25, 2025, Teva Pharmaceuticals and Medincell announced the FDA accepted their sNDA for risperidone (UZEDY) extended-release injectable suspension for adults with bipolar I disorder. The application is based on existing risperidone data and prior evidence supporting risperidone’s use in bipolar I disorder. If approved, risperidone would offer a long-acting treatment option aimed at improving adherence in this patient population.