AbbVie Demonstrates Leadership in Gastroenterology and Hepatology with New Data and Late-Breaking Studies to be Presented at Digestive Disease Week®

NORTH CHICAGO, Ill., May 4, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that data from 20 abstracts in gastroenterology and hepatology programs will be presented at Digestive Disease Week® (DDW) 2017, May 6 – 9, in Chicago.

"AbbVie's research presented at DDW this year represents our commitment to developing innovative new approaches, both through continued HUMIRA research and exploring three promising investigational agents across gastroenterology and hepatology," said Shao-Lee Lin, M.D., Ph.D., Vice President, Therapeutic Areas and International Development, AbbVie. "Building on our deep knowledge and expertise in these areas, we are proud to strive for improved patient outcomes."

AbbVie will present late-breaking studies on two investigational treatments for moderately to severely active Crohn's disease during the Clinical Science: Late-Breaking Abstract Plenary Session on Tuesday, May 9. The late-breaking research includes a Phase 2 study that evaluates the safety and efficacy of multiple dosing regimens of upadacitinib as induction therapy in patients with moderately to severely active Crohn's disease after 16 weeks of treatment. The majority of these patients had failed two or more biologics. Upadacitinib is an investigational oral JAK1-selective inhibitor, which targets an inflammatory pathway that plays an important role in Crohn's disease and several other chronic immune-mediated conditions.

AbbVie will also present a Phase 2, open-label maintenance therapy study that evaluates clinical and endoscopic remission, and clinical and endoscopic response of risankizumab at one year in patients with moderately to severely active Crohn's disease. Risankizumab selectively blocks interleukin-23 (IL-23), a key signaling agent that has been linked to a number of chronic immune-mediated diseases. Risankizumab is an investigational treatment that is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally.

Additionally, AbbVie will present new HUMIRA analyses, including an evaluation of patients with ulcerative colitis treated in a clinical practice setting, an evaluation of the long-term safety of HUMIRA in patients with moderately to severely active Crohn's disease, and an evaluation of the efficacy of HUMIRA in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease.

HUMIRA is one of the most comprehensively studied biologics available for immune-mediated diseases and is supported by more than 14 years of clinical trial experience in inflammatory bowel disease (Crohn's disease and ulcerative colitis).¹

Data from AbbVie's hepatitis C virus (HCV) clinical development program will be presented in six presentations throughout the meeting. These studies provide primary and integrated analysis of treatment with its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients across all major genotypes (GT1-6). The results investigate the potential of G/P in patients with specific treatment challenges and explore a virologic cure* in as little as 8 weeks of treatment for HCV patients without cirrhosis and those new to treatment, who make up the majority of HCV patients. The new drug application (NDA) for G/P has been accepted by the U.S. Food and Drug Administration (FDA) with priority review designation and is currently under review. G/P is an investigational regimen and its safety and efficacy has not been established.

*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. 

Abstracts of Interest

Investigational Crohn's Disease Abstracts of Interest

• Safety and Efficacy of ABT-494 (Upadacitinib), an Oral JAK1 Inhibitor, as Induction Therapy in Patients with Crohn's disease: Results from CELEST; Presentation #874h; Clinical Science: Late-Breaking Abstract Plenary Session; Tuesday, May 9, 10:00 – 10:15 a.m. CT; S103 – McCormick Place
• Efficacy and Safety of Open-Label Maintenance Therapy with Subcutaneous Risankizumab in Patients with Moderate-to-Severe Crohn's disease; Presentation #874l; Clinical Science: Late-Breaking Abstract Plenary Session; Tuesday, May 9, 11:00 – 11:15 a.m. CT; S103 – McCormick Place

Inflammatory Bowel Disease (AbbVie-Sponsored) Abstracts of Interest

• Evaluation of Endoscopic and Deep Remission Outcomes in Adults with Moderate to Severe Crohn's Disease Managed with Treat to Target Approach versus Clinical Symptoms: Data from An Open-Label, MultiCenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease (CALM); Presentation #718; Oral presentation; Monday, May 8, 5:16 – 5:30 p.m. CT; E354a – McCormick Place
• Long-term Safety of Adalimumab in Patients with Crohn's Disease: Final Data from PYRAMID Registry; Presentation #616; Oral presentation; Monday, May 8, 10:15 – 10:30 a.m. CT; S100c – McCormick Place
• Evaluation of Adalimumab on Extraintestinal Manifestations among Patients with Ulcerative Colitis in a Clinical Practice Setting: Results from INSPIRADA; Presentation #Mo1660; Poster presentation; Monday, May 8, 12:00 – 2:00 p.m. CT; South Hall – McCormick Place
• Evaluation of Adalimumab Effectiveness in Anti-Tumor Necrosis Factor-Naïve Pediatric Patients with Crohn's Disease in Clinical Practice; Presentation #Tu1746; Poster presentation; Tuesday, May 9, 12:00 – 2:00 p.m. CT; South Hall – McCormick Place

Investigational Pan-genotypic HCV Regimen Abstracts

• MAGELLAN-1, Part 2: Glecaprevir and Pibrentasvir for 12 or 16 Weeks in Patients with Chronic HCV Genotype 1 or 4 and Prior Direct-acting Antiviral Treatment Failure; Presentation #422; Clinical Plenary Session; Sunday, May 7, 5:00 – 5:15 p.m. CT; S403a – McCormick Place
• High SVR Rates with 8 and 12 Weeks of Pangenotypic Glecaprevir/Pibrentasvir: Integrated Efficacy Analysis of Genotype 1-6 Patients without Cirrhosis; Presentation #429; Oral presentation; Sunday, May 7, 5:15 – 5:30 p.m. CT; S406a – McCormick Place
• Safety and Efficacy of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Infection Genotype 1-6 and Chronic Kidney Disease: An Integrated Analysis; Presentation #510; Oral presentation; Monday, May 8, 9:15 – 9:30 a.m.; S405 – McCormick Place
• EXPEDITION-1: Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Genotype 1,2,4,5 or 6 Infection and Compensated Cirrhosis; Presentation #505; Oral presentation; Monday, May 8, 8:00 - 8:15 a.m.; S405 – McCormick Place
• Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection: An Integrated Analysis; Presentation #Sa1499; Poster presentation; Saturday, May 6, 12:00 – 2:00 p.m. CT; South Hall – McCormick Place
• Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis; Presentation #Sa1498; Poster presentation; Saturday, May 6, 12:00 – 2:00 p.m. CT; South Hall – McCormick Place

Abstracts are available here.

About HUMIRA in the U.S.
Uses²
HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
• Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
• Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Ankylosing spondylitis (AS) in adults.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
• Moderate to severe hidradenitis suppurativa (HS) in adults.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.

Important Safety Information²
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, even if their TB test was negative. 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, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or 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. Children should be brought up to date on all vaccines before starting HUMIRA.

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.

Please click here for the Full Prescribing Information and Medication Guide.

About AbbVie's HCV Clinical Development Program
AbbVie's glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.

G/P is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA)**, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. 
**Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

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 2016 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.

¹ Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006;130(2):323-333. 
² HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc

SOURCE AbbVie

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