Bimzelx Approved by FDA for Psoriasis Treatment

The US 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 medication or phototherapy, according to UCB, a worldwide biopharmaceutical company. Bimekizumab is the first and only licensed psoriasis medication that targets two critical cytokines that drive inflammatory processes: interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

Data from three phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE) that examined the efficacy and safety of bimekizumab in 1,480 individuals with moderate to severe plaque psoriasis were used to support the drug's approval, as per pharmabiz. "Today's FD Approval for Bimzelx is an exciting milestone that reflects our commitment to constantly improving the standard of care in plaque psoriasis and raising expectations about what treatment can deliver." "We know that people with psoriasis value completely clear skin, and in our phase 3 trials, at week 16, 85-91% of patients treated with bimekizumab achieved clear or nearly clear skin, with 59-68% achieving the goal of complete clearance," said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US. "With bimekizumab now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the US."

“Bimekizumab, the first IL-17A and IL-17F inhibitor, has been licensed in the United States for the treatment of individuals with moderate to severe plaque psoriasis. In phase 3/3b trials, bimekizumab outperformed placebo and three existing biologics for psoriasis in terms of skin clearance at week 16, with responses that were fast and lasted up to a year. Long-term data also show that the majority of patients maintained high levels of clinical response for three years," said Mark Lebwohl, MD, bimekizumab investigator and Dean for Clinical Therapeutics at Mount Sinai, as well as Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology.