Dec 20, 2018

AbbVie Submits New Drug Application to U.S. FDA and Marketing Authorization Application to EMA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis.

Dec 20, 2018

AbbVie to Present at the 37th Annual J.P. Morgan Healthcare Conference

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, will participate in the 37th annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019. Michael Severino, M.D., Vice Chairman and President, will present at 10:00 a.m. Central time (8:00 a.m. Pacific time).

Dec 17, 2018

AbbVie Announces Executive Leadership Changes

NORTH CHICAGO, Ill., Dec. 17, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced a new Executive Leadership Team structure designed to streamline its organizational structure and support its long-term growth strategy.  Effective immediately, the new Team will consist of the following individuals, all of whom report to AbbVie Chairman and Chief Executive Officer Richard A. Gonzalez: 

Dec 13, 2018

AbbVie Announces $5 Billion Increase to Stock Repurchase Program

NORTH CHICAGO, Ill., Dec. 13, 2018 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE: ABBV) has authorized a $5 billion increase to AbbVie's existing stock repurchase program.

Dec 13, 2018

Inside our Design Lab: Building a Clinical Trial

Follow Kyle Holen, M.D., Head of AbbVie’s Development Design Center, into the lab where teams design and plan clinical trials.
Dec 05, 2018

Phase 3 Trial of Rova-T as Second-line Therapy for Advanced Small-Cell Lung Cancer (TAHOE Study) Halted

NORTH CHICAGO, Ill., Dec. 5, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.

Dec 04, 2018

IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018

NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today shared results from the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), National Cancer Institute (NCI)-sponsored, Phase 3 study (E1912) evaluating IMBRUVICA® (ibrutinib) plus rituximab versus the current National Comprehensive Cancer Network (NCCN) guidelines Category 1 treatment of fludarabine, cyclophosphamide and rituximab (FCR) in previously untreated younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).1,2 This interim analysis showed that IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS), the primary endpoint of the study, compared to FCR, with a 65 percent reduction in risk of progression or death. Furthermore, IMBRUVICA plus rituximab significantly improved overall survival (OS) compared to FCR. The findings were presented today during the Late-Breaker abstract oral session at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, CA (abstract #LBA-4).

Dec 03, 2018

IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NORTH CHICAGO, Ill., Dec. 3, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced results from the Phase 3 iLLUMINATE (PCYC-1130) trial, evaluating the chemotherapy-free, anti-CD20 combination of IMBRUVICA® (ibrutinib) plus obinutuzumab (Gazyva®) in patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). At a median follow-up of 31 months, study results showed IMBRUVICA plus obinutuzumab significantly prolonged progression-free survival (PFS) (median not reached [NR] vs. 19 months) with a 77 percent reduction in risk of progression or death versus chlorambucil plus obinutuzumab, the current National Comprehensive Cancer Network guidelines Category 1 treatment regimen (hazard ratio [HR] 0.23; 95% confidence interval [CI]: 0.15-0.37; P<0.0001).

Dec 03, 2018

AbbVie Donates $50 Million To St. Jude Children's Research Hospital® To Expand Family-Centered Care

NORTH CHICAGO, Ill. and MEMPHIS, Tenn., Dec. 3, 2018 /PRNewswire/ -- AbbVie, a research-based global biopharmaceutical company, today announced a historic $50 million donation to St. Jude Children's Research Hospital®. This donation will enable St. Jude to accelerate plans to enhance and expand patient and family-centered care at the heart of its mission.

Dec 02, 2018

IMBRUVICA® (ibrutinib) Data in Chronic Lymphocytic Leukemia (CLL) Show up to Seven Years of Progression-free Survival (PFS) in 80 Percent of Previously Untreated Patients, the Longest Follow-up for a Bruton's Tyrosine Kinase Inhibitor to Date

NORTH CHICAGO, Ill., Dec. 2, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the results of up to seven years of clinical trial follow-up for IMBRUVICA® (ibrutinib) monotherapy in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the longest follow-up for a Bruton's tyrosine kinase (BTK) inhibitor to date. The updated Phase 1b/2 data demonstrated durable responses in CLL/SLL patients with an overall response rate (ORR) of 89 percent. Evaluated patients included those with high-risk genomic factors such as complex karyotype and unmutated IGHV, and more than 70 patients with three to 12 prior lines of therapy. Progression-free survival (PFS) rates were also sustained (estimated seven-year rates of 80% for previously untreated patients; 32% in the highly pre-treated relapsed/refractory [R/R] groups). The analysis also found that PFS trended better for R/R patients when treated with ibrutinib in earlier lines of therapy (after one or two prior lines of therapy versus three or more lines of prior therapy).