Company: ABBV
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001551152-25-000049
Chunk: 64

Company: AbbVie Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Part I, Item 1
Chunk 64
---
 prior systemic therapy.

Venclexta

•In June 2025, AbbVie announced that the global Phase 3 VERONA trial evaluating Venclexta in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome did not meet the primary endpoint of overall survival. No new safety signals were observed.

2025 Form 10-Q | 28

•In July 2025, AbbVie announced the submission of a sNDA to the U.S. FDA for the fixed-duration, all oral combination regimen of Venclexta and acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL). The submission is supported by positive results from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen improved progression-free survival compared to standard chemoimmunotherapy in previously untreated patients with CLL. 

Epkinly

•In May 2025, Genmab A/S (Genmab) announced positive topline results from the Phase 3 trial evaluating Epkinly plus rituximab and lenalidomide versus rituximab and lenalidomide alone in adult patients with relapsed or refractory (R/R) follicular lymphoma. 

•In August 2025, Genmab announced that it submitted a supplemental Biologics License Application (BLA) to the U.S. FDA for approval of Epkinly plus rituximab and lenalidomide for the treatment of adult patients with R/R follicular lymphoma.

PVEK

•In September 2025, AbbVie announced the submission of a new BLA to the U.S. FDA for approval of pivekimab sunirine (PVEK), an investigational antibody-drug conjugate (ADC), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). 

Aesthetics

TrenibotE

•In April 2025, AbbVie announced that it submitted a BLA to the U.S. FDA for approval of trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines. TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks.