REG - GSK PLC - US FDA accept 2 depemokimab indication submissions

GSKAnnouncement

03/03/2025 07:15

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RNS Number : 0168Z  GSK PLC  03 March 2025

Issued: 3 March 2025, London UK

 

Depemokimab applications accepted for review by the US FDA for asthma with
type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP)

·  If approved, depemokimab will be the first ultra-long-acting biologic
with 6-month dosing

·  Submissions based on data from positive SWIFT and ANCHOR trials

·  SWIFT-1 and -2 showed depemokimab reduced exacerbation and
hospitalisation rates as an add-on therapy for patients with asthma with type
2 inflammation versus placebo

·  ANCHOR-1 and -2 showed early and sustained reductions in nasal polyp size
and nasal obstruction versus placebo

 

 

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has accepted for review the Biologics License Application for the use of
depemokimab in two indications.

 

The proposed indications are as add-on maintenance treatment of asthma in
adult and pediatric patients aged 12 years and older with type 2 inflammation
characterised by an eosinophilic phenotype on medium- to high-dose inhaled
corticosteroids (ICS) plus another asthma controller and, as add-on
maintenance treatment in adult patients with inadequately controlled chronic
rhinosinusitis with nasal polyps (CRSwNP).

 

The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025.

 

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology &
Inflammation R&D, GSK, said: "Simultaneous regulatory submissions for two
indications highlight our confidence in depemokimab to help reduce the burden
of both asthma and CRSwNP for patients and health systems. Our SWIFT and
ANCHOR trials support depemokimab's potential to suppress interleukin-5
(IL-5), a known driver of type 2 inflammation, to offer patients sustained
inhibition of a key driver of their disease with just two doses per year."

 

Depemokimab, a monoclonal antibody that targets IL-5, is the first
ultra-long-acting biologic to be evaluated in phase III trials and be accepted
for regulatory review for use in these conditions.(1-3) Depemokimab's extended
half-life, high-binding affinity and potency, support six month (26 week)
dosing regimens based on results from the SWIFT and ANCHOR trials.(1-3) In
patients with asthma with type 2 inflammation and patients with CRSwNP, these
trials met their primary endpoints, showing that depemokimab could offer
sustained inhibition of a key driver of their disease, and help achieve key
clinical outcomes with a dosing schedule of just two injections per year.(1-3)
As demonstrated in studies of other diseases, longer intervals between doses
have been shown to overcome barriers to optimal care, such as patient
adherence.(4)

 

IL-5 is a key cytokine (protein) in type 2 inflammation.(1,5,6) Type 2
inflammation is typically identified by blood eosinophil count and is an
underlying driver in many diseases. This type of inflammation is present in
the majority of patients with difficult to treat asthma and can lead to
exacerbations and hospitalisation.(5-7) Type 2 inflammation is also present in
up to 85% of people with CRSwNP and is associated with more severe disease and
symptoms.(8-12)

 

In the United States, more than 26 million people are currently affected by
asthma, 40% of whom report having had at least one asthma attack in the
previous year which contributes to significant burden this condition exerts on
healthcare resources and the lives of patients.(13,14) Each year asthma leads
to an estimated 100,000 hospitalisations and nearly 1 million emergency
department visits and we are determined to help reduce the burden that
respiratory diseases like asthma and CRSwNP exert on patients and healthcare
systems.(14)

 

In the United States, 2.1% of the population are affected by chronic
rhinosinusitis, up to 30% of whom have nasal polyps.(8) People with CRSwNP
experience symptoms such as nasal obstruction, loss of smell, facial pain,
sleep disturbance, infections and nasal discharge that can significantly
affect their emotional and physical well-being.(8-11) Such symptoms mean the
impact of CRSwNP on overall quality of life has been reported to be comparable
with other chronic diseases such as COPD, asthma, and diabetes.(9)

 

Depemokimab is currently not approved for use in any country.

 

About the depemokimab development programme

The phase III asthma programme consists of SWIFT-1 and SWIFT-2 in asthma with
type 2 inflammation, with an open label extension study (AGILE).(1,15) An
additional study (NIMBLE) is underway to assess the efficacy and safety of
depemokimab when participants with asthma with type 2 inflammation are
switched from mepolizumab or benralizumab.(16)

 

The phase III programme in CRSwNP includes two studies, ANCHOR-1 and
ANCHOR-2.(2,3)

 

Depemokimab is currently being evaluated in phase III trials for the treatment
of other IL-5 mediated diseases, including OCEAN for eosinophilic
granulomatosis with polyangiitis (EGPA)(17) and DESTINY for hypereosinophilic
syndrome (HES).(18)

 

About SWIFT-1 and SWIFT-2

SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1), double-blind,
placebo-controlled, parallel-group, multi-centre Phase III clinical trials.(1)
The trials assessed the efficacy and safety of depemokimab as adjunctive
therapy in 382 and 380 participants with severe asthma with type 2
inflammation characterised by blood eosinophil count, including adult and
adolescent patients, who were randomised to receive depemokimab or a placebo
respectively, in addition to their standard of care treatment with medium to
high-dose inhaled corticosteroids plus at least one additional controller.(1)
Number of subjects included in the Full Analysis of SWIFT-1: depemokimab =
250, placebo = 132 and in SWIFT-2: depemokimab = 252, placebo = 128.(1)

 

These results have been reported and published in the New England Journal of
Medicine.(1)

 

About ANCHOR-1 and ANCHOR-2

ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials with the same
primary and secondary endpoints assessing the safety and efficacy of
depemokimab as add-on therapy in adult patients with CRSwNP. (2,3) Both were
52-week, randomised (1:1), double-blind, parallel group, placebo- controlled,
multi-centre trials.(2,3) Number of subjects included in the Full Analysis Set
of ANCHOR-1: depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab =
129, placebo = 128.

 

Both studies met their co-primary endpoints of change from baseline in total
endoscopic nasal polyp score at 52 weeks and change from baseline in nasal
obstruction verbal response scale (VRS) mean score from weeks 49 to 52. The
overall incidence and severity of treatment-emergent adverse events across
ANCHOR-1 and ANCHOR-2 were also similar in patients treated with either
depemokimab or placebo.

 

Full results of ANCHOR-1 and ANCHOR-2 were presented on Saturday 1 March at
the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World
Allergy Organization (WAO) Joint Congress in San Diego and simultaneously
published in The Lancet.(19)

 

About asthma, CRSwNP and type 2 inflammation

Asthma affects more than 260 million people globally, many of whom continue to
experience symptoms and exacerbations despite treatment with high-dose inhaled
corticosteroids plus a second controller (and/or systemic
corticosteroids).(5,20) Asthma presents a significant financial burden to
patients as exacerbations place a resource burden on healthcare systems due to
emergency department visits and hospitalisations.(5,21)

 

CRSwNP is caused by inflammation of the nasal lining that can lead to soft
tissue growths, known as nasal polyps.(8,9) People with CRSwNP experience
symptoms such as nasal obstruction, loss of smell, facial pain, sleep
disturbance, infections and nasal discharge that can significantly affect
their emotional and physical well-being.(8-11 )

 

There is evidence to show IL-5 has broad effects on other structural and
immune and cell types beyond eosinophils, and how they contribute to
inflammation, which can lead to lung remodelling and disease
progression.(5,6,22-26) Ongoing research is generating further evidence to
understand the roles of these cells and their potential contribution to
clinical outcomes in patients with respiratory diseases. Type 2 inflammation
drives the underlying dysfunction of various immune-mediated conditions. IL-5
is a core cytokine (protein) in type 2 inflammation.(4,5) The presence of type
2 inflammation in asthma or CRSwNP can be detected by blood eosinophil count,
which measures the level of a type of white blood cell.(5,10)

 

About GSK in respiratory

GSK is redefining the future of respiratory medicine as it builds on decades
of pioneering work to deliver more ambitious treatment goals and develop the
next-generation standard of care, for hundreds of millions of people with
respiratory diseases. With an industry-leading respiratory portfolio and
pipeline of vaccines, targeted biologics, and inhaled medicines, we are
focused on improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood diseases like refractory chronic
cough or rarer conditions like systemic sclerosis with interstitial lung
disease. GSK is harnessing the latest science and technology with the aim to
modify underlying disease dysfunction and prevent disease progression.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Annual Report for 2024.

 

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References

1.       Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma
With an Eosinophilic Phenotype. NEJM. Published on September 9 at NEJM.org
(https://www.nejm.org/doi/full/10.1056/NEJMoa2406673) .

2.       ClinicalTrials.gov. Efficacy and Safety of Depemokimab
(GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
(ANCHOR-1) Available at: https://clinicaltrials.gov/study/NCT05274750
(https://clinicaltrials.gov/study/NCT05274750) . Accessed February 2025

3.       ClinicalTrials.gov. Efficacy and Safety of Depemokimab
(GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
(ANCHOR-2) Available at: https://clinicaltrials.gov/study/NCT05281523
(https://clinicaltrials.gov/study/NCT05281523) . Accessed February 2025

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(https://ginasthma.org/) .  Accessed February 2025.

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9.       Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis
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CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol
Ital. 2023;43(Suppl. 1):S3-S13.

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and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med
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severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics:
Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.

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(https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/learn-about-asthma/types/severe-asthma)
. Accessed February 2025.

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https://www.lung.org/research/trends-in-lung-disease/asthma-trends-brief/trends-and-burden
(https://www.lung.org/research/trends-in-lung-disease/asthma-trends-brief/trends-and-burden)
. Accessed February 2025.

15.     ClinicalTrials.gov. An Open-Label Extension Study of GSK3511294
(Depemokimab) in Participants Who Were Previously Enrolled in 206713
(NCT04719832) or 213744 (NCT04718103) (AGILE). Available at:
https://clinicaltrials.gov/study/NCT05243680
(https://clinicaltrials.gov/study/NCT05243680) . Accessed February 2025.

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With Mepolizumab or Benralizumab in Participants With Severe Asthma With an
Eosinophilic Phenotype (NIMBLE). Available at:
https://clinicaltrials.gov/study/NCT04718389
(https://clinicaltrials.gov/study/NCT04718389) . Accessed February 2025.

17.     ClinicalTrials.gov. Efficacy and Safety of Depemokimab Compared
With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic
Granulomatosis With Polyangiitis (EGPA) Available at:
https://clinicaltrials.gov/study/NCT05263934
(https://clinicaltrials.gov/study/NCT05263934) . Accessed February 2025.

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https://clinicaltrials.gov/study/NCT05334368
(https://clinicaltrials.gov/study/NCT05334368) . Accessed February 2025.

19.     Gevaert P, et al. Efficacy and safety of twice per year
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ANCHOR-2): phase III, randomised, double-blind, parallel trials. The Lancet.
Published on February 28 at thelancet.com
(https://urldefense.com/v3/__https:/www.thelancet.com/__;!!AoaiBx6H!xEbiVTNleywODU5RtCEXIYmHm_Yt1BlBPEeBJB-nP3PFJ-VuBGC5LRp8B82UXn0vJ0pcQtCBkNeo4vfBhZW9R0JysmlmCsU$)
.

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(https://www.who.int/news-room/fact-sheets/detail/asthma) . Accessed February
2025

21.     Israel, E, et al. Severe and Difficult-to-Treat Asthma in Adults.
N Engl J Med 2017;377:965-76.

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aspirin-exacerbated respiratory disease. J Allergy Clin Immunol.
2021;148(2):574-584.

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functional IL-5 receptor. Allergy. 2020;75(8):2127-2130.

24.     Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts:
Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885.

25.     Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to
airway disease. J Allergy Clin Immunol. 2023;152(4):841-857.

26.     Bergantini L, et al. Regulatory T cell monitoring in severe
eosinophilic asthma patients treated with mepolizumab. Scand J Immunol.
2021;94(1):e13031.

 

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