New FDA Approvals: FDA Grants Additional Indication to Orencia

Oct. 30: The FDA gave an additional approval to Bristol Myers Squibb’s Orencia (abatacept) for the subcutaneous treatment of people at least 2 years old with active psoriatic arthritis. The agency first approved the selective T cell costimulation modulator on Dec. 23, 2005. Dosing for the newest use is 50 mg once weekly for people with a body weight of 10 kg to less than 25 kg, 87.5 mg for those with a body weight of 25 kg to less than 50 kg and 125 mg for those with a body weight of at least 50 kg. The agent also is approved for intravenous dosing of certain indications. GoodRx lists one carton of four 125 mg/mL single-dose syringes as more than $5,520.

Oct. 31: The FDA expanded the approval of Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on Dec. 13, 2022. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The price of two single-dose prefilled pens or two single-dose prefilled glass syringes is $6,576.