Inflammatory Disease Rx Gets Green Light

The US Food and Drug Administration (FDA) has approved a new medication to treat multiple chronic inflammatory diseases.

This new approval is found under the brand name Cyltezo. It contains the active ingredient adalimumab-adbm.

This drug is a biosimilar to Humira. A biosimilar is a biological product that is highly similar to a product that has already been approved, according to the FDA. The previously approved product is known as a reference product. In this case, the reference product is Humira (adalimumab).

Cyltezo was approved to treat multiple types of arthritis, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and arthritis that affects the spine, called ankylosing spondylitis. It was also approved to treat Crohn’s disease, ulcerative colitis and plaque psoriasis.

Cyltezo is to be injected under the skin. Side effects may include infections (such as sinus infections), reactions at the injection site, headache and rash.

Adalimumab-adbm carries a boxed warning noting a risk for serious infections, which includes a risk of tuberculosis (TB). Because of this risk, your health care provider will test you for TB before starting treatment. Another serious risk of this medication is the potential for lymphoma and other cancers, according to the FDA.

Ask your health care provider any questions you may have about treating inflammatory diseases.

Boehringer Ingelheim Pharmaceuticals manufactures Cyltezo.

Written By Anyssa Garza, PharmD, BCMAS