Tue-15-10-2024, 11:50 AM
Currently you need two shots at 160mg each, but soon in the USA and EU you will be able to get one shot at 320mg
Source: ucb.com
Bimzelx (bimekizumab)
Quote:
UCB today announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx).
These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration.
“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “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 eight weeks.”
The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as two 1 mL subcutaneous injections, in healthy study participants. This is the second worldwide approval for the 320 mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.
These new device presentations will be available in the U.S. in Q1 2025.
Source: ucb.com
Bimzelx (bimekizumab)