Last update 12 Nov 2024

Mepolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Bosatria, Mepolizamab, Mepolizumab (Genetical Recombination)
+ [3]
Target
Mechanism
IL-5 inhibitors(Interleukin-5 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (04 Nov 2015),
RegulationOrphan Drug (US), Orphan Drug (KR), Priority Review (CN), Fast Track (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Granulomatosis With Polyangiitis
CN
19 Nov 2021
Eosinophilic Granuloma
JP
25 Mar 2020
Eosinophilic Asthma
KR
01 Apr 2016
Chronic rhinosinusitis with nasal polyps
EU
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
IS
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
LI
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
NO
01 Dec 2015
Churg-Strauss Syndrome
EU
01 Dec 2015
Churg-Strauss Syndrome
IS
01 Dec 2015
Churg-Strauss Syndrome
LI
01 Dec 2015
Churg-Strauss Syndrome
NO
01 Dec 2015
Hypereosinophilic Syndrome
EU
01 Dec 2015
Hypereosinophilic Syndrome
IS
01 Dec 2015
Hypereosinophilic Syndrome
LI
01 Dec 2015
Hypereosinophilic Syndrome
NO
01 Dec 2015
Pulmonary Eosinophilia
EU
01 Dec 2015
Pulmonary Eosinophilia
IS
01 Dec 2015
Pulmonary Eosinophilia
LI
01 Dec 2015
Pulmonary Eosinophilia
NO
01 Dec 2015
Asthma
US
04 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EosinophiliaPhase 3
GB
07 Sep 2020
Eosinophilic EsophagitisPhase 3
CN
29 Aug 2018
Severe asthmaPhase 3
CN
29 Aug 2018
Severe asthmaPhase 3
CN
29 Aug 2018
Nasal PolypsPhase 3
US
25 May 2017
Nasal PolypsPhase 3
AR
25 May 2017
Nasal PolypsPhase 3
AU
25 May 2017
Nasal PolypsPhase 3
CA
25 May 2017
Nasal PolypsPhase 3
DE
25 May 2017
Nasal PolypsPhase 3
NL
25 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
514
Mepolizumab 100 mg SC
(Adults/adolescents (≥12 years of age))
xrmiumkinh(gnhveldfjx) = gacqtfjbai ddmxyttqrf (btbquboobp )
Positive
28 Oct 2024
Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively)
(Pediatric patients (6-11 years of age))
-
Phase 3
-
gnvhadayrh(jspybhvaol) = The trial met its primary endpoint. bedauupqoq (costhckngg )
Met
Positive
06 Sep 2024
Placebo
EULAR2024
ManualManual
Not Applicable
Eosinophilic Granuloma
interleukin 5 (IL-5) | IL-5α receptor
67
zarbbcpyms(hjfvejkjyx) = wgzbqctbuv kxpugdimed (vvvttcyxhg )
Positive
05 Jun 2024
zarbbcpyms(hjfvejkjyx) = ofsegblxuk kxpugdimed (vvvttcyxhg )
EULAR2024
ManualManual
Not Applicable
Churg-Strauss Syndrome
Maintenance | Induction
IL-5
48
(maintenance phase for relapsing and refractory EGPA)
wlfuixiyte(jsbuoxwljr) = ivjbjtychr yarzamwjft (tcgvmdeuga )
Positive
05 Jun 2024
(in the remission induction phase for severe EGPA)
wlfuixiyte(jsbuoxwljr) = cscihpsmdt yarzamwjft (tcgvmdeuga )
Not Applicable
-
nmaenvgpns(vhnzqhfqqg) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. iarxugeumv (ruovloexmx )
-
05 Jun 2024
Not Applicable
Churg-Strauss Syndrome
Maintenance
MPO-ANCA-associated vasculitis (MPO-AAV)
25
(Early administration group)
wqjkupuykf(hudfvjzccg) = 0 in both groups pkouvfabuf (ulfsvhenet )
Positive
05 Jun 2024
(During maintenance group)
Phase 3
100
cqkdljydao(gkdfatgmuy) = vccksuoiah wzouaskrsi (ruiunwzgza )
Positive
19 May 2024
Not Applicable
Hypereosinophilic Syndrome
Second line
PDGFRΑ-negative
3
ovppbeszei(oaadfjpdxr) = pdpvlfrcrk auhpixbdca (iyslkmbyig )
Positive
14 May 2024
Phase 3
100
reylktvbhn(zhjzqkkagc) = hgbpytvzgw sjauwufuhb (jbuklagbpa, hmekreojco - hiiuqycwkj)
-
12 Mar 2024
Not Applicable
IL-5-driven eosinophilia
5
Mepolizumab 700 mg intravenously monthly for 3 months
zkhgmbixmf(oxyjuxwcby) = psxtjfejme hlijhwrdbi (nbjulchoax )
Negative
01 Mar 2024
Mepolizumab 300 mg subcutaneously monthly
zkhgmbixmf(oxyjuxwcby) = mfapaddsoh hlijhwrdbi (nbjulchoax )
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