FDA approves higher-dose Bimzelx prefilled syringes, autoinjectors
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The FDA has approved 320 mg pre-filled syringes and autoinjectors of Bimzelx for the treatment of active psoriatic arthritis with coexisting moderate-to-severe plaque psoriasis, according to a press release from UCB.
The devices will be available in the United States in the first quarter of 2025. Currently, a 160 mg dose of Bimzelx (bimekizumab-bkzx, UCB) is already available in pre-filled syringes and autoinjectors for adults with moderate to severe plaque psoriasis.
“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” Emmanuel Caeymaex, executive vice president, head of patient impact and chief commercial officer at UCB, said in the release. “With the new device presentations, people with moderate to severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single injection every 8 weeks.”
The 320 mg dose of bimekizumab-bkzx is recommended for adults with moderate to severe plaque psoriasis and adults with active psoriatic arthritis and coexisting moderate to severe plaque psoriasis. A 160 mg dose is recommended in all other indications, including adults with ankylosing spondylitis and active psoriatic arthritis.
The FDA’s approval comes after that of the European Commission in August, according to the release. It is based on data from studies that evaluated, in healthy participants, the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection vs. two 1 mL injections.
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