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Biopharmaceuticals FDA

 News Release - March 30, 2017

U.S. FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's HUMIRA(R) (adalimumab) Prescribing Information

NORTH CHICAGO, Ill., March 30, 2017 -- (Healthcare Sales & Marketing Network) -- AbbVie (ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. HUMIRA is now the first-and-only biologic treatment with data on fingernail psoriasis in its U.S. prescribing information.

Fingernail psoriasis affects half of all psoriasis patients.1,2 It is a form of chronic plaque psoriasis characterized by pitting, deformation, thickening, discoloration, pain and separation of the nail from the nail bed.1,3 Nail psoriasis can also contribute to social stigmatization and impact quality of life. 2

"Fingernail psoriasis is often difficult to treat, and we are pleased the FDA recognized the importance of these data so that more healthcare providers can make informed medical decisions when prescribing treatments for those living with psoriasis," said John Medich, Ph.D., vice president, clinical development, Immunology, AbbVie. "AbbVie's nearly 20 years of research in immunology provides us with in-depth knowledge of challenging diseases and allows us to identify ways to address them - it is our hope that the fingernail psoriasis data will support healthcare providers treating this difficult condition."

The Phase 3 study was dedicated to evaluating fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. The study demonstrated nearly half of adult patients treated with HUMIRA achieved an assessment of clear or minimal with at least a two-grade improvement from baseline in signs and symptoms of fingernail psoriasis compared to 6.9 percent of placebo patients (p<0.001). No new safety signals for HUMIRA were observed in the study.

In 2008, HUMIRA was FDA approved to treat adults with moderate to severe chronic plaque psoriasis 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. These fingernail psoriasis data are included as a third psoriasis study (Study Ps-III) in the plaque psoriasis clinical studies section (14.8) of the HUMIRA label and can be found here.

About the Phase 3 Fingernail Psoriasis Study4

This Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study (NCT02016482) evaluated the safety and efficacy of HUMIRA in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis. During the first 26-weeks, enrolled patients (n=217) were randomized to receive HUMIRA 40mg every other week (n=109) starting one week after an initial 80mg dose or matching placebo (n=108). The primary endpoint was met, with 48.9 percent of HUMIRA-treated patients achieving a Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a two-grade improvement from baseline at week 26 versus 6.9 percent for placebo patients (p<0.001).

Through 26 weeks, there were no new safety signals with HUMIRA 40mg every other week. Adverse events (AEs) were reported by 56.9 percent of HUMIRA-treated patients and 55.6 percent of placebo-treated patients. Serious AEs were reported by 7.3 percent and 4.6 percent, respectively, including serious infections in 3.7 percent of those treated with HUMIRA compared to 1.9 percent receiving placebo. The difference between these two groups was not statistically significant.

About HUMIRA in the U.S.

Uses7 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.
  • 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 Information8

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 see 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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 29,000 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.

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.

References
  1. Pasch MC. Nail psoriasis. Drugs. 2016;76(6):675-705.
  2. R.G. Langley, J.H. Saurat, K. Reich, et al. Recommendations for the treatment of nail psoriasis in patients with moderate to severe psoriasis: a dermatology expert group consensus. J Eur Acad Dermatol Venereol. 2011;26:373-381.
  3. Treating specific locations: Hands, Feet and Nails. National Psoriasis Foundation website. Available at: https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails. Accessed February 3, 2017.
  4. Elewski BE, Rich PA, Okun MM, et al. Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. Abstract P131. 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France. 2016:1-8.
  5. About Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis. Accessed February 3, 2017.
  6. Rigopoulos D. (2014). Nail Psoriasis From A to Z. DOI: 10.1007/978-3-319-08810-5. Accessed May 20, 2016. Available at: http://link.springer.com/book/10.1007/978-3-319-08810-5.
  7. Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.
  8. HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated November 28, 2016. Accessed February 16, 2017.


Source: AbbVie

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