Abbott gets another FDA OK for Humira

Ankylosing spondylitis (AS), an autoimmune disease affecting the spine and large peripheral joints, is the third of six autoimmune diseases targeted for Humira (adalimumab) therapy that has received FDA approval. The drug is also approved in the US to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently underway evaluating Humira’s potential in other autoimmune diseases.

The approval of Humira for the treatment of patients with active AS is based on data from the phase III ATLAS trial, results from which showed that Humira was successful in reducing pain and inflammation in patients with AS after 12 weeks of treatment, the study’s primary endpoint.

Other findings demonstrated significant improvement in measures of disease activity for many patients treated with Humira that were first observed at week two and maintained through 24 weeks.

“The approval of Humira in the treatment of ankylosing spondylitis marks an important milestone for Abbott,” said Dr Rebecca Hoffman, divisional vice president of immunology development at Abbott. “Humira is now approved to treat three forms of autoimmune rheumatic diseases – all of them chronic, progressive, debilitating diseases where patients have limited treatment options.”

The recommended dose of Humira for AS is 40mg every other week, by subcutaneous injection, the usual dose recommended for Humira in the treatment of moderate to severe RA and PsA.

Beginning in August, patients will be able to use the Humira Pen, a new delivery device for the self-administration of Humira. Approved by the FDA in June, the Humira Pen is said to offer improved ease of use and a less painful experience compared to the Humira pre-filled syringe.