- Approval marks fourth indication for VRAYLAR, backed by proven efficacy and well-established tolerability as an adjunctive treatment for major depressive disorder (MDD) with an antidepressant therapy (ADT), showing improvement in symptoms when compared to placebo + ADT
NORTH CHICAGO, Ill., Dec. 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC). The sNDA submission is based on results from a Phase 3 clinical trial, which met the primary and secondary endpoints, evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to17 years. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated for the treatment of adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).
NORTH CHICAGO, Ill., Dec. 12, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that for the tenth consecutive year, it has been named to the Dow Jones Sustainability World Index (DJSI World) and Dow Jones Sustainability North America Index (DJSI North America). Additionally, AbbVie achieved the highest score in the biotech sector on the 2022 S&P Global Corporate Sustainability Assessment (CSA). Since AbbVie's founding in 2013, the company has been listed on the DJSI World and DJSI North America every year.
NORTH CHICAGO, Ill., Dec. 11, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced data from multiple clinical trials evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, alone or in combination for the treatment of patients with relapsed/refractory (R/R) follicular lymphoma (FL), previously untreated FL, R/R diffuse large B-cell lymphoma (DLBCL), as well as Richter's syndrome at the 64th American Society of Hematology (ASH) Annual Meeting.
NORTH CHICAGO, Ill., Dec. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF). The exploratory analysis suggests the combination of navitoclax and ruxolitinib led to reductions in bone marrow fibrosis (BMF) and variant allele frequency (VAF) for common genetic mutations found in individuals with myelofibrosis that may indicate potential disease modification.1 The findings were shared in an oral presentation (abstract #237) at the 64th American Society of Hematology Annual Meeting & Exposition (ASH).
NORTH CHICAGO, Ill., Dec. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new and updated data across clinical and real-world studies in chronic lymphocytic leukemia (CLL). Presentations featured during the 64th American Society of Hematology (ASH) Annual Meeting and Exposition will include two clinical trials investigating once daily, fixed-duration treatment with IMBRUVICA® (ibrutinib) plus VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) in adults with CLL and several analyses from real-word data evaluating front-line treatment in CLL.
NORTH CHICAGO, Ill., Nov. 23, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the 5th Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, November 29, 2022. Rob Michael, vice chairman and president, Jeffrey R. Stewart, executive vice president, commercial operations, Scott Reents, senior vice president and chief financial officer, and Tom Hudson senior vice president, R&D and chief scientific officer, will present at 9:55 a.m. Central time.
- Third approved indication for SKYRIZI® (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's disease in the European Union (EU)
- A significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo1,2,3
- A significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance1,2,3
- Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care4,5,6
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