AbbVie: Inaprubahan ng FDA ang update sa label ng Rinvoq para sa UC at CD

Inaprubahan ng FDA ang supplemental NDA na nag-a-update sa indication statement ng Rinvoq, na nagpapahintulot sa paggamit nito bago ang TNF blockers sa mga pasyenteng may UC at CD na hindi maaaring gamitin ang TNF therapy at nakatanggap na ng hindi bababa sa isang aprubadong systemic therapy. Pinalalawak nito ang populasyon ng mga karapat-dapat na pasyente at inaalis ang dating kinakailangang step-through para sa ilang pasyente.

Mahahalagang fact

Na-file: Okt 31, 2025, 11:51 AM
Kaganapan: Update sa FDA label
Direksyon: Positibo
Kumpanya: ABBVAbbVie
Asset: upadacitinib
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 abbv-20250930xexhibit991.htm EX-99.1 Document PRESS RELEASE AbbVie Reports Third-Quarter 2025 Financial Results • Reports Third-Quarter Diluted EPS of $0.10 on a GAAP Basis, a Decrease of 88.6 Percent; Adjusted Diluted EPS of $1.86, a Decrease of 38.0 Percent; These Results Include an Unfavorable Impact of $1.50 Per Share Related to Acquired IPR&D and Milestones Expense • Delivers Third-Quarter Net Revenues of $15.776 Billion, an Increase of 9.1 Percent on a Reported Basis or 8.4 Percent on an Operational Basis • Third-Quarter Global Net Revenues from the Immunology Portfolio Were $7.885 Billion, an Increase of 11.9 Percent on a Reported Basis, or 11.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.708 Billion; Global Rinvoq Net Revenues Were $2.184 Bi

SEC 8-K