ABBV · 10-Q · 2026Q2 · Full report
Regulatory Approval Milestones
AbbVie Inc. · 2026-08-03 · Importance 7 · Surprise 60 · In source text
AbbVie obtained U.S. and European approvals expanding Skyrizi into pediatric plaque psoriasis and Venclexta/Venclyxto into previously untreated chronic lymphocytic leukemia combinations. Decnupaz was approved in the United States for adults with blastic plasmacytoid dendritic cell neoplasm, and European approvals expanded Rinvoq into non-segmental vitiligo and severe alopecia areata. European regulators approved Aquipta for acute migraine treatment, Tepkinly with lenalidomide and rituximab for relapsed/refractory follicular lymphoma, and Maviret for acute hepatitis C in adults and children aged three and older. Boey received European approval for glabellar lines and Skinvive by Juvederm received U.S. approval for reducing neck lines, while the FDA issued a Complete Response Letter for Boey’s U.S. application requesting additional manufacturing information without identifying safety or efficacy concerns.
Key facts
- In April 2026 AbbVie submitted an application to the U.S. FDA for Skyrizi subcutaneous induction for treatment of adult patients with moderately to severely active Crohn’s disease. source
- In June 2026 the European Commission approved Skyrizi for treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. source
- In June 2026 the U.S. FDA approved Skyrizi for treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. source
- In February 2026 AbbVie submitted a U.S. FDA application for Rinvoq for non-segmental vitiligo. source
- In April 2026 AbbVie submitted a U.S. FDA application for Rinvoq for severe alopecia areata. source
- In July 2026 the European Commission approved Rinvoq for treatment of adult and adolescent patients with non-segmental vitiligo. source
- In July 2026 the European Commission approved Rinvoq for treatment of adult and adolescent patients with severe alopecia areata. source
- In June 2026 AbbVie announced the EC approved Qulipta for the acute treatment of migraine in adults with or without aura. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | In April 2026 AbbVie submitted an application to the U.S. FDA for Skyrizi subcutaneous induction for treatment of adult patients with… |
| revenue | positive | realized | — | In June 2026 the European Commission approved Skyrizi for treatment of children six years of age and older with moderate-to-severe plaque… |
| revenue | positive | realized | — | In June 2026 the U.S. FDA approved Skyrizi for treatment of children six years of age and older with moderate-to-severe plaque psoriasis… |
| revenue | positive | probable | — | In February 2026 AbbVie submitted a U.S. FDA application for Rinvoq for non-segmental vitiligo. |
| revenue | positive | probable | — | In April 2026 AbbVie submitted a U.S. FDA application for Rinvoq for severe alopecia areata. |
| revenue | positive | realized | — | In July 2026 the European Commission approved Rinvoq for treatment of adult and adolescent patients with non-segmental vitiligo. |
| revenue | positive | realized | — | In July 2026 the European Commission approved Rinvoq for treatment of adult and adolescent patients with severe alopecia areata. |
| revenue | positive | probable | — | In June 2026 AbbVie announced the EC approved Qulipta for the acute treatment of migraine in adults with or without aura. |
| revenue | positive | probable | — | In February 2026 the U.S. FDA approved Venclexta in combination with acalabrutinib for previously untreated adult patients with chronic… |
| revenue | positive | probable | — | In May 2026 the European Commission authorized an expanded label for Venclyxto to include use in combination with acalabrutinib (with or… |
| revenue | positive | probable | — | In July 2026 the European Commission granted marketing authorization for Tepkinly in combination with lenalidomide and rituximab for adult… |
| revenue | positive | probable | — | In May 2026 the U.S. FDA approved Decnupaz (pivekimab sunirine-pvzy) for treatment of adult patients with blastic plasmacytoid dendritic… |