FDA Approves Maxigesic ® IV to be Marketed in the U.S. as Combogesic ® IV (acetaminophen and ibuprofen) for the Management of Pain
October 18, 2023FDA Approval for Generic to Votrient
October 19, 2023October 18, 2023 – UCB, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
The FDA recommended dosage of bimekizumab for psoriasis patients is 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12 and 16, then every 8 weeks thereafter. For patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered.
Bimekizumab may be administered by a healthcare professional, or a patient may self-inject after proper training. It is available as an autoinjector and a pre-filled syringe and will be available in the U.S. in approximately one month.