AbbVie GK in Japan and Eisai’s subsidiary EA Pharma recently launched an auto-injection delivery system for Humira (adalimumab) to help patients with chronic inflammatory conditions such as juvenile arthritis.
The Humira Pen is designed for subcutaneous injection of 40 mg (0.4 mL) or 80 mg (0.8 mL) of Humira, a fully human monoclonal antibody against tumor necrosis factor (TNF)-alpha. TNF-alpha is a protein that plays a key role in the inflammatory response in juvenile arthritis, other types of arthritis, and autoimmune diseases.
The new pen-type auto-injector device was developed to make life simpler for patients when self-injecting the medication. The rounded pen-type body of Humira Pen is specially engineered to fit in the hands of patients who have a weaker grip, and to conceal the needle tip when injected.
Humira Pen comes with a lock function and auto-injection delivery system that allows a full drug injection in 10 seconds, alerting patients to the start and end of the injection with a sound and an inspection window.
Both pen devices (the 40 mg and the 80 mg doses) are filled with the same drug solution as the conventional Humira prefilled syringe devices.
Humira works by neutralizing TNF-alpha, and was developed as a treatment for multiple chronic inflammatory conditions.
So far, Humira is estimated to have been used by one million patients in over 100 countries.
In Japan, Humira is approved for the the treatment of polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and other inflammatory conditions.
Of note, Humira Pen 80 mg and Humira 80 mg subcutaneous injection syringe have not been approved for the treatment of polyarticular juvenile idiopathic arthritis in Japan.
In the U.S., Humira is approved for the treatment of moderate to severe polyarticular juvenile idiopathic arthritis in children ages 2 and older. The medication can be used alone, or combined with methotrexate or certain other therapies. Humira is also approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other conditions.
Humira is also approved for the treatment of polyarticular juvenile idiopathic arthritis in Europe.
Given Humira’s clinical benefits, several biosimilars have been approved or are currently in development.