According to Ankylosing Spondylitis News, a new treatment, Hulio, has been approved by the FDA. It is a treatment for ankylosing spondylitis and other inflammatory disorders. Although it has been approved, it will not be available to patients in the U.S. until 2023 due to an agreement with AbbVie, the marketer of the drug.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a disorder that causes inflammation in the spine that may spread to other body parts. Symptoms include inflammation of the hips, eyes, knees, shoulders, and joints of the spine and ribs. This inflammation can make breathing and other movements difficult, and issues with the eyes can lead to vision loss. In a small number of cases, the nervous system, lungs, and heart are affected. In terms of a cause, medical professionals believe that a number of environmental and genetic reasons are behind AS. The exact cause is unknown, but there have been multiple genes linked to the disorder. Biologics and NSAIDs are used to treat AS, but a special diet and exercise routine have both been proven to reduce the symptoms.
Developed by Mylan and Fujifilm Kyowa Kirin Biologics, Hulio is a biosimilar of Humira. It has the ability to treat inflammatory disorders, such as ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis, juvenile idiopathic arthritis, ulcerative colitis, Crohn’s disease, and psoriatic arthritis. Patients can choose between auto-injectors and pre-filled syringes.
Although the FDA has approved of Hulio, it will not be available until July 31, 2023. This is due to a patent agreement made with AbbVie, the cretof Humira. The drug is already available to patients in Europe, as the European Commission approved Hulio back in 2018.
Approval was granted after the FDA evaluated the results of the third phase of the ARABESC trial. Participants had rheumatoid arthritis, and results showed that Hulio is very similar to Humira in effectiveness. Hopefully patients will be benefited by this treatment when they have access to it in 2023.