New Presentation, HUMIRA® (adalimumab) 20 mg/0.2 mL for Injection in Pre-filled Syringe (PFS) Launched for Paediatric Patients, together with the Introduction of Fixed Weight Dosing

Maidenhead, UK, 29^th March 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA^® (adalimumab) 20 mg/0.2 mL presentation. The presentation is designed for injection in a pre-filled syringe specifically in paediatric patients for approved indications (paediatric polyarticular juvenile idiopathic arthritis, paediatric enthesitis related arthritis, paediatric Crohn’s disease, paediatric plaque psoriasis and paediatric Uveitis).

The formulation contains the same active ingredient, adalimumab, and the efficacy and safety profile remains unchanged. In 2016 AbbVie introducted a citrate free adalimumab 100 mg/mL formulation and launched Humira 40 mg/0.4 mL. The HUMIRA 20 mg/0.2 mL will be available to the UK Market at the beginning of quarter two (April 2018).

"The launch of the HUMIRA 20 mg/0.2 mL presentation underscores our ongoing dedication to improving the patient experience through research and enhancements,” said Alice Butler, Medical Director, AbbVie. “We remain committed to innovation in immunology in order to improve upon the therapeutic experience of patients and physicians.”

Professor Ramanan, Consultant Paediatric Rheumatologist, Bristol Royal Hospital for Children & Royal National Hospital for Rheumatic Diseases, said: “The introduction of HUMIRA 20 mg/0.2 mL is welcome news for paediatric patients, that will provide significant reduction in pain on administration for paediatric patients”.

Kit Tranter, Lead Paediatric Rheumatology Nurse Specialist at Jenny Lind Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust said: “This will be met positively by the Paediatric Nursing community as the implications for empowering young people and their families, improving quality of life by reducing the technical nature of administering paediatric doses, reducing waste whilst maintaining good control of long term conditions shouldn’t be underestimated. I’m delighted that the specific needs of the paediatric rheumatology patient group have been recognised and acted upon to improve the overall experience”.

The paediatric dosing has been simplified. Instead of using body surface area as a calculation of dose required, the calculation is based on age and weight and will utlilise the newly available HUMIRA 20 mg/0.2mL and current HUMIRA 40 mg/0.4 mL.

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Notes to editors

About HUMIRA® (adalimumab)

For further information, and recommended dosing of HUMIRA for each paediatric indication, please see the Summary of Product Characteristics: http://www.medicines.org.uk/emc.

Important EU Safety Information

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

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UK Media Contacts

Cheryl Pitcher Email: cheryl.pitcher@abbvie.com

Tel: 07500 786 466

References:

1) HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: https://www.medicines.org.uk/emc/search?q=humira. Accessed 28^th March 2018.

Date of preparation: March 2018

Zinc reference no: AXHUM180208