NORTH CHICAGO, Ill., May 12, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 18 abstracts in its gastroenterology and hepatology programs will be presented at Digestive Disease Week® (DDW) 2015, May 16 – 19, in Washington, D.C. The abstracts feature results from studies further evaluating the safety and efficacy of HUMIRA® (adalimumab) and VIEKIRA PAK™ (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets).
"AbbVie remains committed to making a meaningful difference in the lives of patients with serious gastroenterologic and hepatic diseases," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "The depth and breadth of data presented at DDW showcase AbbVie's leadership in these fields, building upon decades of experience and research while deepening our understanding of disease burden and impact."
HUMIRA data being presented include a six-year observational study in patients with moderate to severe Crohn's disease, as well as a post hoc analysis examining durable clinical remission and response in moderate to severe ulcerative colitis. Additionally, AbbVie research analyzing the indirect costs and family burden of pediatric Crohn's disease in the United States will be highlighted in an oral presentation. AbbVie will also present research comparing the patient burden of ulcerative colitis with Crohn's disease, and a study evaluating ulcerative colitis severity.
HUMIRA is one of the most comprehensively studied biologics available and is supported by more than 12 years of physician and patient experience in inflammatory bowel diseases. In the United States, HUMIRA is approved for eight indications, including moderate to severe Crohn's disease in adults, moderate to severe Crohn's disease in children 6 years of age and older and moderate to severe ulcerative colitis in adults.
Data from VIEKIRA PAK's ongoing genotype 1 HCV development program will be presented in both oral and poster sessions throughout the meeting. The studies evaluate safety and efficacy of the regimen, with or without ribavirin, throughout diverse populations seen in clinical practice. Additionally, for the first time, a post hoc analysis of adherence rates from the Phase 3 TURQUOISE-II study in patients with cirrhosis treated with VIEKIRA PAK and ribavirin will be presented.
VIEKIRA PAK was approved in December 2014 in the United States for the treatment of adults with genotype 1 chronic HCV infection, including those who have a certain type of cirrhosis (compensated).
Selected Abstracts of Interest
Abstracts are available here.
HUMIRA (AbbVie-sponsored) Abstracts of Interest
Inflammatory Bowel Disease (AbbVie-sponsored) Abstracts of Interest
VIEKIRA PAK (AbbVie-sponsored) Abstracts of Interest
About HUMIRA
USE
HUMIRA is a prescription medicine used:
IMPORTANT SAFETY INFORMATION
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.
Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.
HUMIRA is given by injection under the skin.
The benefits and risks of HUMIRA should be carefully considered before starting therapy.
This is the most important information to know about HUMIRA. For more information, talk with a healthcare provider.
Please see Full Prescribing Information, including Medication Guide.
About VIEKIRA PAK
USE
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C virus (HCV) infection, including people who have a certain type of cirrhosis (compensated).
VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA PAK.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people should also read the Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
VIEKIRA PAK must not be taken if people:
What should people tell a healthcare provider before taking VIEKIRA PAK?
What are the common side effects of VIEKIRA PAK?
These are not all of the possible side effects of VIEKIRA PAK. A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about VIEKIRA PAK. For more information, talk with a healthcare provider.
Please see Full Prescription Information, including Medication Guide.
People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If people cannot afford their medication, they should contact www.pparx.org for assistance.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
SOURCE AbbVie
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