ABBV News & Events

AbbVie "announced that the FDA has approved DECNUPAZ- pivekimab sunirine-pvzy - for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN. Patients with BPDCN often present with skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects adult men aged 60-70years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options. In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNUPAZ demonstrated clinically meaningful and durable responses. In newly diagnosed patients with BPDCN, researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients who were able to receive post-study treatment stem cell transplant."

The Food and Drug Administration approved pivekimab sunirine-pvzy, or Decnupaz, from AbbVie, a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm. The prescribing information includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of Maviret, an oral pangenotypic direct-acting antiviral therapy for the treatment of acute hepatitis C infection in adults and children aged 3 years and older. The final European Commission decision is expected in the third quarter of 2026. If approved, Maviret would be indicated for both acute and chronic hepatitis C infection in the European Union.

Allergan Aesthetics, an AbbVie company, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Boey for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown in adult patients, when these have an important psychological impact. The European Commission decision, expected in the coming months, would apply across the 30 European Economic Area countries following completion of the centralized procedure.