AbbVie Files EMA Submission for SKYRIZI in Crohn’s Disease Amid Ongoing Lung Cancer Pipeline Progress

AbbVie (NYSE: ABBV) recently submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for a new subcutaneous induction regimen of SKYRIZI® (risankizumab) to treat adults with moderately to severely active Crohn’s disease. The submission is based on data from the Phase 3 pivotal AFFIRM study, positioning SKYRIZI as a potential additional induction option for this patient population. The EMA filing occurred on August 27, 2026, according to the company’s news release dated the same day.

In parallel, AbbVie continues to fuel innovation in oncology, particularly lung cancer. On August 21, 2026, the company announced its participation at the World Conference on Lung Cancer (WCLC) 2026, where it will present new clinical, translational and real-world data spanning its lung cancer portfolio. Highlights include AbbVie’s ABBV‑1480 (RC148), a PD‑1/VEGF bispecific antibody in frontline non–small cell lung cancer (NSCLC), as well as updates on telisotuzumab adizutecan (Temab‑A) and ABBV‑706 in both NSCLC and small cell lung cancer (SCLC).

These developments reaffirm AbbVie’s dual-channel strategy: expanding indications for established immunology assets while also advancing emerging oncology programs. If approved, the EMA’s decision could broaden SKYRIZI’s label and strengthen AbbVie’s Crohn’s disease portfolio in Europe. Simultaneously, the WCLC presentations underscore the company’s commitment to building a next‑generation immuno‑oncology pipeline with promising treatment modalities such as bispecific antibodies and antibody‑drug conjugates.

Investors and industry watchers will closely monitor the EMA’s review timeline as well as data reception at WCLC. Approval for SKYRIZI in Crohn’s disease would complement AbbVie’s existing therapies in inflammatory conditions, while positive clinical feedback from lung cancer programs could lay groundwork for future trial advancement or regulatory filings.

AbbVie shares were last verified at $255.48, reflecting a 1.23% decline as of August 28, 2026. The stock price movement on that day isn’t attributed to either the EMA submission or the WCLC data announcements unless explicitly reported by reliable financial sources.