ABBVIE'S HUMIRA (ADALIMUMAB) RECEIVES FIRST AND ONLY U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
-- HIDRADENITIS SUPPURATIVA (HS) IS A PAINFUL, CHRONIC INFLAMMATORY SKIN DISEASE
-- FDA GRANTED HUMIRA ORPHAN DRUG DESIGNATION FOR MODERATE TO SEVERE HS (HURLEY STAGE II AND HURLEY STAGE III DISEASE) IN MAY
Sep 10, 2015
NORTH CHICAGO, Ill., Sept. 10, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). HUMIRA is now the first and only FDA-approved therapy for adults with HS.
Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.1-2 Earlier this year, the FDA granted HUMIRA orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides HUMIRA the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS.
Other treatment options for people with HS include surgery to remove skin affected by the disease and antibiotics to treat infections that may occur.3 HS can be progressive in some people, and diagnosing and managing the disease early is important.4 This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment.1-2 It's important for HS patients and people who think they may have HS to see a dermatologist who is trained to recognize and manage the disease.4
"The symptoms of HS, including inflamed nodules and abscesses, can have a significant impact on patients during their most active years of life," said Alexa Kimball, M.D., M.P.H., director of the Clinical Unit for Research Trials and Outcomes in Skin at Massachusetts General Hospital, professor of dermatology at Harvard Medical School and principal investigator. "Adalimumab significantly reduced the signs of HS in clinical trials, and this FDA approval provides a much needed development in treatment options for patients."
"We are pleased that people living with hidradenitis suppurativa now have an FDA-approved treatment option for this chronic, debilitating disease," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to making a remarkable impact on the lives of patients, and hidradenitis suppurativa is an area of particular unmet need."
The FDA approval for HS adds to the comprehensive record of clinical studies that HUMIRA has established over its 17 years of use in immunology. This FDA approval is based on the results of two pivotal Phase 3 studies, PIONEER I and PIONEER II, and represents the ninth approved indication for HUMIRA in the U.S.
PIONEER I and PIONEER II included 633 people with moderate to severe HS. Patients in these studies were randomly assigned to receive either HUMIRA or placebo in addition to daily use of topical antiseptic. Both studies showed that more patients given HUMIRA had reductions in the total number of abscesses and inflammatory nodules than patients given placebo. No new safety risks were identified in these trials.5-6 More information on PIONEER I and PIONEER II is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233, respectively).
In July, the European Commission approved HUMIRA for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment in the European Union.7
Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 843,000 patients worldwide.8
About HUMIRA in the U.S.
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 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.
Important Safety Information9
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 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.
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.
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.
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.
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Dufour DN, Emtestam L, Jemec GB. Hidradenitis Suppurativa: A Common and Burdensome, Yet Under-Recognised, Inflammatory Skin Disease. Postgrad Med J. 2014; 90 (1062):216-21.
Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.org/diseases-conditions/hidradenitis-suppurativa/basics/definition/con-20027334. Published April 9, 2013. Accessed August 12, 2015.
American Academy of Dermatology. Hidradenitis suppurativa. Available at: http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e---h/hidradenitis-suppurativa. Accessed August 12, 2015.
Safety and Efficacy of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from First 12 Weeks of PIONEER I, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract #210 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark 2014.
Efficacy and Safety of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from PIONEER II, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract FC08.2. 22nd Congress of the European Dermatology and Venereology (EADV) Meeting, Amsterdam, Netherlands 2014.
HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; August 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Accessed August 12, 2015.
AbbVie Data on File.
Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.