dm+d

40033211000001102

Refrigerated Storage

Bimzelx UCB Pharma Limited

UCB Pharma Limited
Bimzelx
160 mg solution for injection in pre-filled syringe or pen

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled pen or syringe may be stored at room temperature (up to 25°C) for a single period of maximum 25 days. Once removed from the refrigerator and stored under these conditions, discard after 25 days or by the expiry date printed on the container, whichever occurs first.

23 February 2022
London MI Service

New Medicines

Bimzelx Moderate-to-severe chronic plaque psoriasis in adults

Information

Bimzelx
New molecular entity
UCB Pharma
UCB Pharma

Development and Regulatory status

Launched
Launched
Not approved
September 2021
May 22FDA has issued a complete response letter for bimekizumab in adults with moderate to severe plaque psoriasis. It is reported to be related to pre-approval inspection issues which will need to be resolved before approval [25]
Sep 21Launched in UK. Price 160mg/ml pre-filled syringe or pen, 2=£2,443 [24].
Aug 21Approved in UK [23].
Aug 21Approved in EU; regulatory review by MHRA is underway [22].
Jun 21Recommended for EU approval by CHMP – the full indication is “Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimzelx will be available as a 160mg solution for injection [20].
Feb 21Bimekizumab is considered by analysts to be the tenth most anticipated drug launch of 2021 [15].
Sep 20Filed in US [11].
Aug 20Filed in EU via centralised procedure [10].
Nov 19UCB pharma plan to file regulatory submissions mid-2020 [5].
Sep 18Global launch expected 2021 [3].

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Moderate-to-severe chronic plaque psoriasis in adults
Parenteral

Further information

Yes

Trial or other data

Sep 22In PIII BE BRIGHT study, >80% of patients who achieved complete skin clearance (PASI 100) after 16 weeks of bimekizumab treatment maintained PASI 100 response and health-related QOL outcomes for three years with continuous maintenance dosing [26].
Aug 21 In PIII BE BRIGHT study, > 90% of patients who achieved clear or almost clear skin (IGA 0/1) after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing [21].
Apr 21Results of PIII BE RADIANT published in NEJM [19].
Apr 21Results of PIII BE SURE RCT published in NEJM [18].
Apr 21Published PIII trial BE SURE met its secondary endpoints. The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified [16]
Apr 21Published PIII trial BE RADIANT results showed pts treated with bimekizumab achieved complete skin clearance (PASI 100) at week 16 of 61.7% vs 48.9% for pts treated with secukinumab (p<0.001). Superior levels of PASI 100 were also demonstrated up to week 48 of therapy. The trial also met all secondary endpoints. The most common treatment-emergent adverse events (TEAEs) with bimekizumab were upper respiratory tract infections (38.9%), oral candidiasis (19.3%) and urinary tract infection (6.7%). Oral candidiasis cases were predominantly mild or moderate and none led to discontinuation. Over 48 weeks, the incidence of serious TEAEs was 5.9% with bimekizumab vs 5.7% with secukinumab. [16, 17]
Feb 21In PIII trial BE VIVID (n=567), bimekizumab was more effective than ustekinumab and placebo in terms of achievement of PASI90 at week 16 (85% versus 50% and 5%, respectively; both p<0.0001) and IGA response of clear or almost clear (84% versus 53% and 5%; both p<0.0001) [14].
Feb 21In PIII trial BE READY (n=435), PASI90 was achieved in 91% of patients receiving the IL-17F and IL-17A inhibitor bimekizumab (320mg every 4 weeks) compared to 1% receiving placebo (p<0.0001), and an IGA score of 0 or 1 was achieved in 93% v 1%, respectively (p<0.0001) [13].
Oct 20More detailed results have been released for the PIII BE SURE study; 86.2% of patients treated with bimekizumab achieved almost clear skin (PASI 90), compared with 47.2% of patients treated with adalimumab at week 16 (p<0.001).1 Additionally, 85.3% of patients treated with bimekizumab achieved IGA0/1, versus 57.2% of patients treated with adalimumab at week 16 (p<0.001) [12].
Jul 20PIII trial BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating the superiority of bimekizumab over secukinumab for complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100) [9].
Jun 20In PIII trial BE READY randomized withdrawal study, participants were randomized to bimekizumab 320mg Q4W or placebo for the first 16 weeks. Bimekizumab was superior to placebo in achieving PASI 90 and IGA 0/1 at week 16; over 90 percent of participants receiving bimekizumab achieved PASI 90 or IGA 0/1, while 68.2 percent achieved complete skin clearance (all p<0.001) [9].
Dec 19PIII active-controlled BE SURE study compared bimekizumab to adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab in achieving at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90). The study also met all secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100 [6].
Nov 19UCB has announced positive results from the PIII BE READY study; bimekizumab met its co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo [7].
Oct 19PIII BE VIVID study (n=570) meets primary endpoint [5].
Jun 19In PIII trial BE VIVID with active comparator ustekinumab, patients treated with bimekizumab 320 mg every four weeks (Q4W) achieved significantly superior skin clearance than those receiving placebo or ustekinumab at week 16, as measured by PASI 90 and IGA 0/1 [8].
Sep 18PIII BE BRIGHT trial to evaluate the long-term safety and tolerability of bimekizumab in adults with moderate to severe chronic plaque psoriasis starts (NCT03598790; PS0014). The trial is enrolling 1,120 patients in the US and Japan, and is expected to complete collection of primary outcome data in May 21 [2].
Jun 18PIII BE RADIANT trial to compare the efficacy of bimekizumab versus secukinumab in patients with moderate to severe chronic plaque psoriasis starts (PS0015; NCT03536884). The study intends to enrol 700 patients in the US [2].
Feb 18 PIII BE READY trial to compare the efficacy of bimekizumab versus placebo in patients with moderate to severe plaque psoriasis starts (PS0013; NCT03410992). The trial will enrol 435 patients in the US, and is expected to complete collection of primary outcome data in Feb 19 [2].
Jan 18PIII BE SURE trial to compare the efficacy and safety of bimekizumab versus adalimumab in patients with moderate to chronic plaque psoriasis starts (PS0008; NCT03412747). It will enrol 450 patients in the US [2].
Dec 17PIII BE VIVID trial to compare the efficacy of bimekizumab versus placebo and an active comparator ustekinumab, in the treatment of subjects with moderate to severe chronic plaque psoriasis starts (NCT03370133; PS0009). The trial is enrolling 560 patients in the US [2].

Evidence based evaluations

Bimzelx Psoriatic arthritis

Information

Bimzelx
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Sep 22EMA accept MAA for bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA) [10].
Jan 22UCB Pharma plan to submit regulatory applications to FDA and EMA Q3 22 [7].

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
The prevalence varies from 20-420 per 100,000 population across the world, except in Japan where it is 1 per 100,000 [1].
Psoriatic arthritis
Parenteral

Trial or other data

Jul 22Open-label extension of PII BE ACTIVE RCT (NCT02969525; n=206), found efficacy demonstrated at week 48 was sustained at week 152 (52.9% achieved American College of Rheumatology criteria 50% response, 57.7% achieved 100% skin clearance as per PASI, and 51.5% achieved minimal disease activity) [9].
May 22UCB announce initial results from PIII studies. At week 16, treatment with bimekizumab improved symptoms vs. placebo, with a consistent clinical response across biologic-naïve (43.9% vs. 10%; p<0.001) and TNF-inadequate responder populations (43.4% vs. 6.8%; p<0.001) [8].
Jan 22PIII BE COMPLETE study (NCT03896581) meets primary endpoint [7].
Nov 21UCB announce positive topline results from PIII BE OPTIMAL study (n=852); biologic-naive patients treated with bimekizumab achieved superior ACR50 response vs placebo at week 16 [6].
Feb 21Estimated primary completion date for PIII BE OPTIMAL (NCT03895203) is now August 2021 [5].
Dec 19PIII trial (NCT03895203) estimated primary completion July 2021 [4].
Apr 19UCB Biopharma initiated the phase III BE-OPTIMAL trial to evaluate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously compared with placebo in the treatment of subjects with active psoriatic arthritis (EudraCT2017-002322-20; NCT03895203). The randomised, double-blind trial intends to enrol approximately 840 patients in the US [2]; the estimated primary completion date is July 2021 [3].
Mar 19CB initiated a phase III trial to evaluate the clinical efficacy, safety and tolerability of bimekizumab (SC) compared with placebo in the treatment of tumour necrosis factor alpha-inadequate responders (TNFα-IR) patients with active psoriatic arthritis (EudraCT2017-002804-29; NCT03896581). The double blind, randomised trial intends to enrol approximately 390 patients in the US [2].
Jul 18UCB completed a phase IIb trial that investigated the efficacy, safety and tolerability of bimekizumab in patients with active psoriatic arthritis (BE ACTIVE; PA0008; EudraCT2016-001103-23; NCT02969525). The dose-ranging, randomised, double-blind, parallel, placebo-controlled trial was initiated in October 2016 and recruited 206 patients in the US, Czech Republic, Germany, Russia, Hungary and Poland [2].

Evidence based evaluations

Bimzelx Ankylosing spondylitis (AS)

Information

Bimzelx
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Sep 22EMA accepts filing of MAA for bimekizumab for the treatment of adult patients with active axial spondyloarthritis. Axial spondyloarthritis includes both non-radiographic axSpA and ankylosing spondylitis. The application is based on data from the PIII BE MOBILE 1 study in non-radiographic axSpA and the PIII BE MOBILE 2 study in ankylosing spondylitis [5].

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Prevalence is 0.1-2% of the general population, with the highest prevalence in northern European countries and the lowest in people of Afro-Caribbean descent [1].
Ankylosing spondylitis (AS)
Subcutaneous injection

Trial or other data

Dec 21UCB announces positive top-line interim analysis from PIII BE MOBILE 2 study. The study met its primary endpoint, as measured by the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16, when compared to placebo. The study also met all ranked secondary endpoints, including significant improvements in patient-reported disease activity, as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [4]
Sep 21Estimated primary completion date for PIII BE MOBILE 2 is August 2021 [3].
Apr 19PIII BE MOBILE 2 study to evaluate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS) starts (NCT03928743). 300 adults will be recruited in the US, Hungary, Poland and Belgium. Primary outcome is assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at week 16; collection of these data is due to complete Jan 21 [2].

Evidence based evaluations

Bimzelx Non-radiographic axial spondyloarthritis

Information

Bimzelx
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
Pre-registration (Filed)
Phase III Clinical Trials
Sep 22EMA accepts filing of MAA for bimekizumab for the treatment of adult patients with active axial spondyloarthritis (axSpA) [9].
Jan 21UCB plan to file bimekizumab for axial spondlyoarthritis in the US and EU in Q3 22 [5].

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Non-radiographic axial spondyloarthritis
Subcutaneous injection

Further information

Yes
Topic has been prioritised

Trial or other data

Jul 22Open-label extension of PII BE AGILE RCT (NCT02963506; n=303), found efficacy demonstrated at week 48 was sustained at week 156 (53.7% & 28.0% patients achieved ASAS40 and partial remission, respectively; mean ASDAS reduced from 3.9 at baseline to 2.1 at week 48 and 1.9 at week 156) [8].
May 22Improved ASAS40 response rate vs placebo (primary endpoint) at week 16 was 47.7% vs 21.1% in PIII BE MOBILE 1 and 44.8% vs 22.5% in BE MOBILE 2 (p<0.001 for both). BASDAI score and quality of life measures also improved [7].
Jan 22In PIII BE MOBILE 1 study bimekizumab led to at least 40% improvement compared to baseline across measurements of disease activity, spinal pain, physical function and inflammation at week 16. The chronic inflammatory disease primarily impacts the spine and joints that link the pelvis and lower spine [5].
Jan 22UCB announces positive top-line interim analysis results showing that PIII BE MOBILE 1 study met the primary and all ranked secondary endpoints. Bimekizumab demonstrated a statistically significant and clinically meaningful improvement over placebo in the proportion of patients who achieved ASAS40 at week 16, the primary endpoint of the study [6].
Dec 21BE MOBILE 2 study (n=322) meets its primary endpoint based on proportion of patients achieving ASAS40 response (measure of improvements in disease across different domains) at week 16 vs. placebo. No new safety findings reported [4].
Feb 21Estimated primary completion date for PIII BE MOBILE 1 is now September 2021 [3].
Apr 19BE MOBILE 1 study (NCT03928704) to evaluate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA) starts. 240 adults will be recruited in the US, Belgium, Hungary and Poland. Primary outcome is assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at week 16; collection of these data is due to complete Feb 21 [2].

Evidence based evaluations

Bimzelx Moderate to severe hidradenitis suppurativa

Information

Bimzelx
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Monoclonal antibody that targets interleukin-17, that binds and neutralises both IL-17A and IL-17F.
Hidradenitis suppurativa is a chronic persistent or recurrent suppurative disease of unknown cause occurring in the apocrine follicles, usually affecting the groin and axillae and also other apocrine-bearing sites such as the breasts, perineum and buttocks. The prevalence in Europe has been estimated to be in the region of 1%. Overall it occurs more often in women [1].
Moderate to severe hidradenitis suppurativa
Subcutaneous injection

Further information

Yes

Evidence based evaluations