The HCPFive: Top News for Healthcare Providers from the Week of 10/12

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 (FDA) acceptance of a supplemental biologics license application (sBLA) seeking approval for insulin human (Afrezza) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes, approval of a supplemental new drug application (sNDA) updating the indication statement for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), and clearance of the Elecsys pTau181 test for ruling out Alzheimer-related amyloid pathology, as well as phase 3 data demonstrating the benefits of a prescription digital therapeutic for schizophrenia and iptacopan (Fabhalta) for slowing IgA nephropathy (IgAN) progression.

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 October 12, 2025—let’s jump in!

FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes

On October 13, 2025, MannKind Corporation announced the FDA acceptance of the sBLA seeking approval for insulin human (Afrezza) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application is supported by results from the phase 3, 26-week, open-label INHALE-1 study and, with the acceptance, has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.

FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD

On October 13, 2025, the FDA approved a supplemental new drug application (sNDA) updating the indication statement for AbbVie’s upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active UC and CD. The new statement allows the use of upadacitinib after patients have received ≥ 1 approved systemic therapy in the event tumor necrosis factor blockers are clinically inadvisable. Previously, upadacitinib was only indicated for adults who had an inadequate response or intolerance to ≥ 1 blockers.

FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology

The FDA cleared the Elecsys pTau181 test, the first blood test to rule out Alzheimer-related amyloid pathology. Intended for patients aged ≥ 55 years with presenting Alzheimer Disease symptoms, the test can assist the initial assessment for Alzheimer Disease and other causes of cognitive decline in the primary care setting.

Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial

On October 13, 2025, Boehringer Ingelheim and Click Therapeutics announced phase 3 data showing their investigational prescription digital therapeutic, used as an adjunct to antipsychotic therapy, significantly reduced experiential negative symptoms in patients with schizophrenia. The data were presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam.

APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint

On October 16, 2025, Novartis announced positive final results from the phase 3 APPLAUSE-IgAN study of iptacopan (Fabhalta) in adults with IgAN. In the trial, the oral alternative complement pathway inhibitor demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over 2 years. Of note, Novartis plans to use these data to support regulatory submissions for iptacopan in 2026.

References

1. MannKind. MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes. October 13, 2025. Accessed October 17, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental

2. AbbVie. U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease. October 13, 2025. Accessed October 17, 2025. https://news.abbvie.com/2025-10-13-U-S-Food-and-Drug-Administration-FDA-Approves-Updated-Indication-Statement-for-RINVOQ-R-upadacitinib-for-the-Treatment-of-Inflammatory-Bowel-Disease

3. Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology. Diagnostics. Published October 6, 2025. Accessed October 17, 2025. https://diagnostics.roche.com/us/en/news-listing/2025/fda-cleared-ptau181-alzheimers-blood-test.html

4. Boehringer. Boehringer and Click Therapeutics present pivotal data for investigational prescription digital therapeutic CT-155 showing a statistically significant reduction in negative symptoms of schizophrenia. Prnewswire.com. Published October 13, 2025. Accessed October 17, 2025. https://www.prnewswire.com/news-releases/boehringer-and-click-therapeutics-present-pivotal-data-for-investigational-prescription-digital-therapeutic-ct-155-showing-a-statistically-significant-reduction-in-negative-symptoms-of-schizophrenia-302582119.html

5. Novartis. Novartis Fabhalta® (iptacopan) meets Phase III primary endpoint, slows kidney function decline in patients with IgA nephropathy (IgAN). October 16, 2025. Accessed October 17, 2025. https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-meets-phase-iii-primary-endpoint-slows-kidney-function-decline-patients-iga-nephropathy-igan