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UCB potential multi-billion blockbuster Bimzelx approved for plaque psoriasis | FDA | iPharmaCenter

UCB is celebrating a significant milestone as the Food and Drug Administration (FDA) approved Bimzelx (bimekizumab). This groundbreaking drug is now authorized for moderate to severe plaque psoriasis in adult patients considered candidates for systemic therapy or phototherapy.

Bimekizumab sets itself apart as a trailblazing psoriasis treatment, being the first and only medication designed to selectively inhibit two pivotal cytokines that drive inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

UCB is expecting peak revenues of more than EUR 4 billion.

The green light for bimekizumab stems from a wealth of compelling data gathered through three rigorously conducted Phase 3 clinical trials: BE READY, BE VIVID, and BE SURE. These trials encompassed a broad spectrum of 1,480 adults grappling with moderate to severe plaque psoriasis, and their outcomes played a significant role in securing FDA approval.

The recommended dosage for psoriasis patients prescribed with bimekizumab is 320 mg, administered as two subcutaneous injections of 160 mg each. This initial treatment is given at Weeks 0, 4, 8, 12, and 16, followed by injections every eight weeks. In cases where patients weigh 120 kg or more, healthcare providers may consider administering a dose of 320 mg every four weeks after week 16. A healthcare professional can administer bimekizumab, or patients can undergo self-injection after proper training. This medication is available in two forms: an autoinjector and a pre-filled syringe, and it will be accessible to patients in the U.S. in approximately one month.

Key insights derived from the extensive Phase 3 clinical development program are illuminating. In these trials, bimekizumab showcased its efficacy and safety compared to placebo, ustekinumab (BE VIVID), and adalimumab (BE SURE). All of these studies successfully met their co-primary endpoints, as well as their secondary endpoints.

Patients who received bimekizumab experienced a substantial improvement in skin clearance by week 16 compared to those who were administered ustekinumab, placebo, and adalimumab.

This improvement was gauged by achieving a Psoriasis Area and Severity Index (PASI 90) and obtaining an Investigator's Global Assessment (IGA) response indicative of clear or nearly clear skin (IGA 0/1). Secondary endpoints such as PASI 75 at week four and PASI 100 (complete skin clearance) at week 16 were also met.

Notable findings from these trials encompass the following aspects:

  • Clear or Almost Clear Skin: Eight out of ten patients receiving bimekizumab at a dosage of 320 mg every four weeks (Q4W) attained PASI 90 and IGA 0/1 by week 16.

  • Complete Skin Clearance: Roughly six out of ten patients receiving bimekizumab (320 mg Q4W) achieved PASI 100 by week 16.

  • Speed of Response: Clinical responses triggered by bimekizumab were swift, with over seven out of ten patients achieving PASI 75 at week four after just one dose (320 mg).

  • Maintenance of Response: Encouragingly, clinical responses obtained with bimekizumab at week 16 (PASI 90 and PASI 100) were sustained for up to one year. Long-term data revealed that clinical responses remained robust in most patients even after three years of bimekizumab treatment.

As with any medical treatment, there are potential side effects. The most commonly reported adverse reactions (≥ 1%) observed in patients taking bimekizumab include upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.


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