AbbVie Receives Orphan Drug Designation for HUMIRA® (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Moderate-to-Severe Hidradenitis Suppurativa (HS)

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

- HS, a chronic, immune-mediated skin disease characterized by inflamed areas including nodules and/or abscesses, has no cure and no approved medications

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AbbVie

May 15, 2015, 09:44 ET

NORTH CHICAGO, Ill., May 15, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease), a painful, chronic inflammatory skin disease. AbbVie's supplemental Biologic License Application seeking FDA approval for the use of HUMIRA in patients with moderate-to-severe HS is currently under review with the agency. HUMIRA is not currently approved by regulatory authorities for the treatment of HS.

"Patients living with hidradenitis suppurativa have limited treatment options and often experience severe, painful symptoms that can significantly impact their lives," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We are committed to researching treatment options to address the unmet needs of the dermatology community and we are pleased that the FDA has issued this designation and recognizes the treatment potential of HUMIRA."

HS, sometimes referred to as "acne inversa" by dermatologists, is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication. The disease is characterized by inflamed areas typically located around the armpits and groin, between the buttocks and under the breasts. A number of physical signs are associated with HS – namely, painful abscesses and nodules, sinus tracts and scarring. The symptoms associated with HS may lead to limited movement and psychological strain that impact the lives of patients.

Physicians typically assess the signs and symptoms of HS on a scale developed from a clinical measure of severity called the Hurley Staging System. Hurley Stage II manifests with recurrent abscesses with sinus tracts and scarring, single or multiple widely separated lesions. In Hurley Stage III, patients present with either spread or interconnected abscesses.

About Orphan Drug Designation

Orphan drugs are entitled to seven years of market exclusivity if approved by the FDA for a rare disease. The Orphan Drug Designation program provides orphan status to drugs and biologics which 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 drug.

The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval for an investigational use. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

About HUMIRA in the U.S.
Uses
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 conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also 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.
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.

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.

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

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