NORTH CHICAGO, Ill., Dec. 6, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic therapy. The study found ibrutinib demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate (ORR) of 67%.2 Final results from this study presented today as a late-breaking oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (abstract #LBA-3). IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
NORTH CHICAGO, Ill., Dec. 5, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced efficacy and safety findings from a Phase 2 study demonstrating that nearly half (48%) of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) had a complete or partial response with single-agent ibrutinib (IMBRUVICA®), as assessed by Independent Review Committee (IRC) investigators. The median duration of response was not reached.1 These data will be presented today in an oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (abstract #1213). IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
NORTH CHICAGO, Ill. and BALTIMORE, Dec. 5, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, and the Johns Hopkins University School of Medicine today announced that they signed a five-year collaboration agreement with the goal of advancing medical oncology research and discovery at both organizations.
NORTH CHICAGO, Ill. and CHICAGO, Dec. 5, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, and Northwestern University today announced they signed a five-year collaboration agreement with the goal of advancing research and discovery in oncology. Together, AbbVie and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University will work in several areas of oncology research, which in addition to others could include, lung, colorectal, breast, prostate and hematological cancer.
NORTH CHICAGO, Ill., Dec. 4, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced encouraging efficacy and safety findings from two separate studies evaluating ibrutinib (IMBRUVICA®) as a combination therapy in two of the most common types of non-Hodgkin's lymphoma: diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
NORTH CHICAGO, Ill., Dec. 3, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced long-term follow-up results evaluating up to five years of IMBRUVICA® (ibrutinib) use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In this analysis, 89% of treatment-naïve (TN) and relapsed/refractory (R/R) patients with CLL/SLL, including those with high-risk disease, show a complete or partial response. Further, almost one-third of patients (29%) who received ibrutinib as their first treatment for the disease achieved a complete response (CR), and patients lived without disease progression longer when treatment was started earlier in the course of the disease (abstract #233).
- Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases[1]
NORTH CHICAGO, Ill., Nov. 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients; mITT excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
NORTH CHICAGO, Ill., Nov. 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. If approved, HUMIRA will become the first and only biologic treatment option for patients 12 years of age and older. HUMIRA was approved for adults with moderate to severe HS by the European Commission in July 2015.
NORTH CHICAGO, Ill., Nov. 11, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12 rates with 8 weeks of treatment with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) across all major chronic hepatitis C virus (HCV) genotypes. In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711).
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