The HCPFive: Top News for Healthcare Providers from the Week of 10/18

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 final 24-month phase 3 VISIONARY data showing Otsuka’s sibeprenlimab (Voyxact) stabilizes eGFR decline in IgA nephropathy, the FDA approval of BioCryst’s berotralstat (Orladeyo) 150 mg oral pellets for hereditary angioedemaprophylaxis in patients aged ≥12 years, the FDA accelerated approval of AstraZeneca’s ravulizumab (Ultomiris) as the first C5 complement inhibitor indicated in IgA nephropathy, the FDA approval of AbbVie’s subcutaneous induction regimen for risankizumab (Skyrizi) in adults with moderately to severely active Crohn’s disease, and the FDA approval of GSK’s bepirovirsen (Hibsago) as the first antisense oligonucleotide approved for chronic hepatitis B.

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 18, 2026 — let’s jump in!

1. Sibeprenlimab Stabilizes eGFR Over 24 Months in IgA Nephropathy: VISIONARY

Final 24-month data from the phase 3 VISIONARY trial showed Otsuka’s sibeprenlimab (Voyxact), a selective APRIL inhibitor, produced an annualized eGFR slope of +0.3 mL/min/1.73 m² per year versus a placebo decline of 4.2 — a treatment difference of 4.5 mL/min/1.73 m² per year (P<.0001). The least-squares mean eGFR change from baseline favored sibeprenlimab by 9.2 mL/min/1.73 m² at 2 years, and 24-hour uPCR fell 61.3% from baseline versus 1.3% with placebo. Benefit was consistent across prespecified subgroups defined by proteinuria level, baseline eGFR, and SGLT2 inhibitor use, and Otsuka has initiated a rolling sBLA seeking traditional approval based on the 24-month eGFR endpoint.

2. FDA Approves Berotralstat Oral Pellets for Adults, Adolescents With HAE

On October 21, 2026, the FDA approved BioCryst’s berotralstat (Orladeyo) 150 mg oral pellet formulation for prophylaxis of hereditary angioedema attacks in patients aged ≥12 years, adding a pellet alternative to the existing capsule for adults and adolescents. The pellet formulation had previously been approved for children aged 2 to <12 years in December 2025; the new 150 mg strength is intended to allow those patients to remain on pellets as they age into adolescence, and to serve adults who have difficulty swallowing capsules. Berotralstat remains the first and only targeted oral prophylactic therapy covering the full HAE population from age 2 and older.

3. Ravulizumab Receives FDA Accelerated Approval for IgA Nephropathy

On October 21, 2026, the FDA granted accelerated approval to AstraZeneca’s ravulizumab (Ultomiris) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression, making it the first and only C5 complement inhibitor indicated in IgAN and the drug’s fifth approved indication. The approval was based on a prespecified interim analysis of the phase 3 I CAN trial, in which ravulizumab reduced 24-hour UPCR by 43.4% versus placebo at week 34 (P<.0001), with reductions observed as early as week 10. Continued approval is contingent on the trial’s second primary endpoint — eGFR change at week 106 — with those late-breaking results presented at ASN Kidney Week on October 23, 2026.

4. FDA Approves Subcutaneous Risankizumab Induction for Crohn’s Disease

On October 23, 2026, the FDA approved a subcutaneous induction regimen for AbbVie’s risankizumab (Skyrizi) in adults with moderately to severely active Crohn’s disease, based on the phase 3 AFFIRM trial, in which 56% of patients achieved clinical remission at week 12 versus 30% with placebo. The approval allows patients to initiate therapy at home via on-body injector at weeks 0, 2, 4, and 8, rather than requiring intravenous infusion — though IV induction remains an option. Approximately 65% of AFFIRM participants had previously failed advanced therapy, supporting the new regimen’s use even in a refractory population.

5. FDA Approves Bepirovirsen for Chronic Hepatitis B

On October 20, 2026, the FDA approved bepirovirsen (Hibsago; GSK/Ionis), the first antisense oligonucleotide approved for chronic hepatitis B virus (HBV) infection, for use alongside existing nucleos(t)ide analogue therapy in adults without cirrhosis with suppressed HBV DNA and HBsAg ≤3,000 IU/mL. The approval was supported by two replicate phase 3 B-Well trials showing a 19% functional cure rate in eligible patients — compared to less than 1% with standard of care alone — with 24% of bepirovirsen-treated patients meeting criteria to discontinue all hepatitis B therapy. The FDA granted the drug Fast Track, Breakthrough Therapy, and Priority Review designations; a companion diagnostic to identify eligible patients was also authorized.