FDA approves adalimumab-adbm autoinjector pen for JIA, Crohn’s disease

FDA approves adalimumab-adbm autoinjector pen for JIA, Crohn’s disease | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved Boehringer Ingelheim’s new adalimumab-adbm (Cyltezo) pen, allowing an autoinjector option, according to a press release from the company. Adalimumab-adbm is an FDA-approved interchangeable biosimilar to adalimumab (Humira; AbbVie), indicated to treat multiple chronic inflammatory diseases, including juvenile idiopathic arthritis (JIA) and Crohn’s disease in pediatric populations.

According to Boehringer Ingelheim, the 40 mg/0.8 mL pre-filled pen will be available on July 1, 2023, in 2-, 4-, and 6-pack options. The design features a 1-button, 3-step activation, with 100% drug visibility and a protected needle.

The adalimumab-adbm injection for subcutaneous use is indicated to reduce signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years and older. The drug can be used alone or in combination with methotrexate in this indication.

Adalimumab-adbm is also indicated to treat moderate to severe active Crohn’s disease in pediatric patients 6 years and older, as well as adult patients. Further, the drug is indicated for adult patients to reduce signs and symptoms of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and to treat ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

In adalimumab clinical trials, the most common adverse reactions (>10%) were infections (e.g. upper respiratory, sinusitis), injection site reactions, headaches, and rash.

Patients on adalimumab-adbm should not receive live vaccines and, if possible, pediatric patients should be up to date with all immunizations before initiating adalimumab-adbm therapy. The safety of administering live or live-attenuated vaccines in infants that are exposed to adalimumab products in utero is not known, and risks and benefits should be considered before vaccinating (live or live-attenuated) exposed infants.

Lymphoma and other malignancies have been reported in children and adolescents treated with Tumor Necrosis Factor (TNF) blockers including adalimumab products. According to the press release, most reported TNF blocker cases occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young male patients. Nearly all of these patients, “received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of [hepatosplenic T-cell lymphoma] is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants,” according to Boehringer Ingelheim.

Reference:

US FDA approves the Cyltezo Pen, a new autoinjector option, ahead of July 1 commercial launch. Boehringer Ingelheim. May 22, 2023. Accessed May 22, 2023. https://www.boehringer-ingelheim.com/us/press-releases/fda-approves-autoinjector-pen-interchangeable-biosimilar