Delving into the Latest Updates on Grass pollen allergy immunotherapy(Stallergenes Greer Ltd.) with Synapse

Overview

Basic Info

Drug Type

Allergen extract

Synonyms

300 IR grass pollen allergen extract, Five-grass pollen immunotherapy, Grass pollen allergy immunotherapy

+ [6]

Target-

Action

modulators

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Rhinitis, Allergic, Seasonal

Inactive Indication

House dust mite allergy

Originator Organization

Stallergenes Greer Ltd.

Active Organization

Stallergenes SA

Inactive Organization

Lundbeckfonden

Stallergenes Greer Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Germany (01 Sep 2008),

Rhinitis, Allergic, Seasonal

Regulation-

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Sublingual immunotherapy (SLIT) is a well-tolerated, safe, and effective approach to treating allergic rhinitis (AR). Oralair® is a five-grass pollen SLIT tablet containing natural pollen allergens from five of the major grass species responsible for seasonal AR due to grass pollen allergy. Recommended use is in a pre-coseasonal regimen, starting daily treatment approximately 4 months before the start of the pollen season, with treatment then continued daily throughout the season; treatment should continue for 3-5 y. Clinical efficacy and safety of Oralair® in patients with grass pollen-induced AR has been demonstrated in a comprehensive clinical development program of randomized controlled trials. Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging.

01 Feb 2017·Allergo Journal International

Cost-effectiveness of grass pollen SCIT compared with SLIT and symptomatic treatment

Article

Author: Reinhold, Thomas ; Brüggenjürgen, Bernd

BACKGROUNDWhereas specific immunotherapy (SIT) has already been shown to be cost-effective in the treatment of allergic rhinitis compared with symptomatic treatment, only a small number of investigations have compared sublingual (SLIT) and subcutaneous (SCIT) immunotherapeutic approaches. This analysis discusses the cost-effectiveness of SCIT compared with SLIT and a symptomatic treatment modality. At the same time, particular attention is paid to preparation-specific characteristics.METHODSThe investigation is based on a previously published health economic model calculation. A Markov model, with predefined disease stages and a time period of 9 years, formed the basis of the analysis. The data on specific SCIT (Allergovit®) and SLIT (Oralair®) preparations required for the calculation were adjusted for the present analysis. Quality-adjusted life years (QALYs) based on symptom scores were calculated as the endpoint for effectiveness. Furthermore, the total costs and cost effectiveness of SCIT were determined. Model uncertainties were estimated by means of additional sensitivity analyses.RESULTSWith regard to effectiveness, both the SCIT and SLIT preparations proved superior compared to symptomatic treatment. Although more expensive, SIT seem to be cost-effective. A direct comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed lower total costs for SCIT treatment over the study period (SCIT 1159 € versus SLIT 1322 €) and improved effectiveness (SCIT 7.112 QALYs versus SLIT 7.060 QALYs).DISCUSSIONSIT represents a cost-effective treatment option for patients with allergic rhinitis compared with symptomatic treatment. The comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed SCIT to be predominant and cost-effective, due in particular to somewhat greater patient compliance and lower drug costs. It also became evident that, as far as possible, product-specific model variables are required for an economic evaluation of SIT treatment.

01 Dec 2016·AllergyQ1 · MEDICINE

Similar biological activity in skin prick test for Oralair^® (8200 BAU) and Grazax^® (6200 BAU) reinforces effective SLIT dosing level

Q1 · MEDICINE

Article

Author: Maspero, J. ; Mösges, R. ; Michels, A. ; Matta, J. J. ; Singh, J. ; Rosario, N. ; Esch, R. ; Larenas Linnemann, D. E. S.

AbstractIn Europe, allergen extracts are standardized based on skin prick wheal size in 20–30 allergic subjects. To understand the biological activity of clinically effective Sublingual immunotherapy, we used this method to determine the biological activity of solution and tablet Timothy grass pollen (TIM) extracts, compared to an FDA‐approved extract (Reference) of 10 000 BAU/ml. Blinded, quadruplicate skin prick tests with concentrate and three serial half‐log dilutions allowed the construction of a semilogarithmic regression line per extract. Bioequivalent allergy units (BAU) values were obtained from the comparison with reference. Extracts and dilutions showed a neat linear dose response (all: R2 > 0.98) in 33 rhinitis patients. Relative potencies: Staloral® 12 000 BAU/ml, Soluprick® 10 300 BAU/ml, Oralair® 8200 BAU, and Grazax® 6200 BAU. Even though all extract concentrates differed in wheal size (P = 0.01–0.001), Grazax® producing a 25% smaller wheal size than Oralair®, and the biological activity of these clinically effective TIM tablets led in the same range (6200–8200 BAU; 0.92–1.23 cm2). SLIT dose‐finding studies for other pollens might start with allergen extracts producing 1.1 cm2 wheal surface.

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	Germany	-	01 Sep 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypersensitivity	Phase 1	Poland	Lundbeckfonden	10 May 2021
Hypersensitivity	Phase 1	France	Lundbeckfonden	10 May 2021
Hypersensitivity	Phase 1	Latvia	Lundbeckfonden	10 May 2021
House dust mite allergy	Phase 1	-	Stallergenes Greer Ltd.	01 Oct 2007
Rhinitis, Allergic	Phase 1	-	Stallergenes Greer Ltd.	01 Oct 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00674700 (CTgov)	Phase 2/3	Rhinitis, Allergic \| House dust mite allergy	509	300 IR house dust mites allergen extract tablet (300 IR)	vwdmjxrfwf(jmmapbwizp) = ildmantmzj xhjavuykuu (inobfalyds, vwktnsjsib - lfvkfzmxpz) View more	-	19 May 2016
				500 IR house dust mites allergen extract tablet (500 IR)	vwdmjxrfwf(jmmapbwizp) = pmcxvbtitq xhjavuykuu (inobfalyds, ohjhqxuzob - agbwhlqawq) View more

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