BIMZELX®

Bimekizumab

As the first dual-specific IL-17 A/F inhibitor to treat plaque psoriasis, bimekizumab could be more effective than inhibitors of IL-17A only at reducing skin and joint inflammation as well as pathological bone formation, which are the primary contributors to the symptomatic burden of psoriasis, and with fewer side effects than some current treatment options, including a pan-IL-17 inhibitor. Prior approvals for the treatment of moderate to severe plaque psoriasis by the European Commission (EC), Japan’s Ministry of Health, Labour and Welfare (MHLW), Health Canada and Australia’s Therapeutic Goods Administration bode well for approval by the U.S. Food and Drug Administration (FDA).

About bimekizumab

  1. UCB
  2. Humanized IgG1 monoclonal antibody (mAb)
  3. Subcutaneous injection every four weeks for the first five treatments, then every eight weeks to treat moderate to severe plaque psoriasis
  4. Also being studied to treat axial spondyloarthritis, psoriatic arthritis and hidradenitis suppurativa
  5. ~11.7 million symptomatic psoriasis cases in the G7 markets in 2021
  6. 80-90% of patients with psoriasis have plaque psoriasis

Why is it a drug to watch?

Bimekizumab is the first dual IL-17 A/F inhibitor to treat moderate to severe plaque psoriasis. Phase 3 trial results showed superior skin clearance outcomes than existing treatments. Its less-frequent dosing schedule and good safety profile will likely be attractive to clinicians and patients.

  1. EC and MHLW approvals were supported by results from three phase 3 trials, BE VIVID (bimekizumab vs ustekinumab/STELARA®), BE READY (bimekizumab vs placebo) and BE SURE (bimekizumab vs adalimumab/HUMIRA®):
    • All three studies met co-primary endpoints.
    • Bimekizumab showed statistically significant superior levels of skin clearance at week 16 (≥90% improvement on the Psoriasis Area Severity Index [PASI]).
    • Responses at week 16 were maintained for up to one year in all studies.
  2. The phase 3 BE RADIANT trial (bimekizumab vs the first-in-class IL-17 inhibitor, secukinumab/COSENTYX®) showed statistically significant superiority at skin clearance on the PASI 100 (100% reduction from baseline on the PASI).
  3. Positive top-line results from the multiple phase 3 trials for psoriatic arthritis, recently published in The Lancet, hold promise for its effectiveness in this patient population
    • BE OPTIMAL: biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve adults with active psoriatic arthritis
    • BE COMPLETE: adults with active psoriatic arthritis who were inadequate responders or intolerant to anti-TNF-alpha therapy
  4. It was the first drug to receive NICE approval via its new fast-track approval scheme introduced in 2021; the decision was based on clinical trial evidence showing better effectiveness with bimekizumab than with three competitors previously approved by NICE. The cost-effectiveness estimates resulted in NICE recommendation for the estimated 18,000 people who will be eligible for the treatment.

Review and approval status

August 2021:
For patients with moderate to severe plaque psoriasis who are candidates for systemic therapy:
• Marketing authorization: EC

January 2022:
For patients with moderate to severe plaque psoriasis, generalized pustular psoriasis or psoriatic erythroderma:
• Marketing authorization: MHLW

February 2022:
For patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy:
• Marketing authorization: Canada

September 2022:
For patients with psoriatic arthritis (PsA):
• Marketing authorization application: EC

September 2022:
For patients with active axial spondyloarthritis (axSpA):
• Marketing authorization application: EC

November 2022:
For patients with moderate to severe plaque psoriasis: (axSpA):
• Biologics License Application resubmitted: U.S.

Actual and expected launch:
• 2021: Europe
• 2022: Japan
• 2023: United States

Patents estimated to expire beginning in 2027

How will bimekizumab impact the market for plaque psoriasis?

  1. Its selective dual inhibition makes it stand apart from the already available IL-17 inhibitors, COSENTYX and ixekizumab (TALTZ®), as well as the IL-17 receptor antagonist, brodalumab (SILIQ®), which has a black box warning for suicidal ideation and behavior.
  2. Physicians report higher-than-expected primary failure with both COSENTEX and TALTZ, and given the black box warning for SILIQ, there is opportunity for bimekizumab to fill both efficacy and safety gaps.

What gaps in treatment does bimekizumab fill?

The less frequent dosing of bimekizumab (every eight weeks) is more convenient than that of TNF-alpha inhibitors and other IL-17 inhibitors approved for this patient population. The chronicity and time requirement of clinic visits take a toll on patient quality of life, particularly those of working age. In addition, bimekizumab is among the few drugs approved for rare types of psoriasis, such as generalized pustular psoriasis and psoriatic erythroderma, in Japan. Further validation of its safety and efficacy for these conditions could expand its use to treat these patients in other countries and regions.

What hurdles might it need to overcome to reach blockbuster status?

As a fourth-in-class IL-17 entrant, bimekizumab will enter a competitive market in which new therapies, regardless of their improved clinical profiles, tend to be reserved for TNF-alpha and ustekinumab treatment-refractory patients with primary or secondary nonresponse until physicians are comfortable with the long-term safety of a new treatment. Increasing treatment choices will make treatment decisions more complex, and bimekizumab will be competing with efficacious biologics, biosimilars and the targeted oral drugs Otezla® and SOTYKU.

Entry in the U.S. market has been delayed first by COVID-19-related travel restrictions at the timing of its initial PDUFA date of October 15, 2021, and second by the FDA’s complete response letter (CRL) in May 2022 owing to gaps found during inspection of UCB’s European manufacturing facilities. These delays could limit the sales potential in the United States and potentially negatively affect stakeholders’ perceptions.

$2.045B
expected sales in 2027
90%
probability of success for bimekizumab in the United States for psoriatic arthritis.

Drug Timeline & Success Rates

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