AbbVie Receives Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab from the U.S. Food and Drug Administration for the Treatment of Pediatric Patients with Crohn's Disease

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Nov 30, 2016, 02:00 ET

- Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases[1]

- Risankizumab is an investigational treatment being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma, that selectively blocks interleukin-23 (IL-23) – a key signaling agent that has been linked to a number of chronic immune-mediated diseases

- Crohn's disease is an incurable chronic, inflammatory condition of the gastrointestinal tract that can cause diarrhea, abdominal pain and weight loss[2]

NORTH CHICAGO, Ill., Nov. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients.

Risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma. 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. Risankizumab is not currently approved by regulatory authorities.

"AbbVie is committed to providing innovative treatment options to patients, particularly in areas with unmet medical needs such as Crohn's disease in children – a disease that may impact physical and social development,"³ said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "This designation reinforces the need for additional treatment options for young people living with this sometimes debilitating disease. Our expertise in immunology provides a unique perspective and we look forward to continuing to evaluate risankizumab as a potential new therapy for patients."

Crohn's disease is a type of inflammatory bowel disease which commonly involves the end of the small intestine and the large intestine.² Children living with Crohn's disease may be affected by a delay in growth and sexual maturation, and may experience symptoms similar to those in adults including diarrhea, abdominal pain, rectal bleeding and weight loss.^2-4

The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.¹

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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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," of AbbVie's 2015 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.

References:

U.S. Government Publishing Office. Orphan Drugs. 21 CFR §316. http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0e737d105ef9a1632b19a1e713b93cc4&mc=true&n=pt21.5.316&r=PART&ty=HTML. Accessed November 9, 2016.
What Is Crohn's Disease? Crohn's and Colitis Foundation of America website. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease. Accessed November 9, 2016.
Grossman AB, Baldassano RN. Inflammatory bowel disease. In: Kliegman R, et al., eds. Nelson Textbook of Pediatrics. 19th ed. Philadelphia: W.B. Saunders Co;2011:1294-1304.
Crohn's Disease & Ulcerative Colitis: A Guide For Parents. Crohn's and Colitis Foundation of America website. http://www.ccfa.org/resources/guide-for-parents.html. Accessed November 9, 2016.