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October 22, 2021October 22, 2021 – Cyltezo® (adalimumab-adbm – Boehringer Ingelheim) has received U.S. FDA approval to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients who are at least two years old, and to treat moderately to severely active Crohn's disease in patients who are at least six years old.
- Cyltezo first received FDA approval in 2017. At that time, its indication for pJIA was limited to patients at least four years of age, while its Crohn's disease indication was limited to adult patients. The drug is also approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.
- Recommended dosing is based on the indication as well as the patient's age and weight. Cyltezo is injected subcutaneously and can be administered by the patient or a caregiver at home, as well as by a healthcare provider.
- A biosimilar for Humira® (adalimumab – AbbVie), Cyltezo is expected to launch in 2023. It will be automatically interchangeable with Humira, meaning a pharmacist can substitute Cyltezo for Humira without needing to obtain a new prescription from the patient's prescriber. It is only the second biosimilar to win FDA approval as automatically interchangeable with its reference product.