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-

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

Stallergenes Greer Ltd.Lundbeckfonden

Drug Highest PhaseApproved

First Approval Date

DE (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 Nov 2017·The journal of allergy and clinical immunology. In practiceQ1 · MEDICINE

Safety Review of 5-Grass Pollen Tablet from Pooled Data of Clinical Trials

Q1 · MEDICINE

Article

Author: Wahn, Ulrich ; Golden, David B K ; Didier, Alain ; Bons, Brigitte ; Cox, Linda S ; Casale, Thomas B

BACKGROUND:

The 5-grass pollen sublingual tablet has been approved for the treatment of grass pollen-induced allergic rhinoconjunctivitis in subjects with or without intermittent asthma.

OBJECTIVE:

To provide a comprehensive analysis of the safety profile of the 5-grass tablet on the basis of pooled data from 8 clinical trials.

METHODS:

Subjects (5-65 years old) with medically confirmed grass pollen-induced allergic rhinoconjunctivitis were included in the double-blind studies. Those with intermittent asthma not requiring treatment other than inhaled beta-2 agonists could participate. Randomized subjects received a 5-grass or placebo tablet daily 2 or 4 months preseasonally and coseasonally (5 single-season studies, over 3 years in a long-term study) or outside the season (phase I studies). Adverse events were pooled and analyzed descriptively.

RESULTS:

Among 2,512 subjects enrolled, 1,514 received the 5-grass tablet. A total of 1,038 adults and 154 pediatric (5-17 years old) subjects were treated with the 300 Index of Reactivity dose (vs 840 and 158 placebo recipients, respectively); 17% had intermittent asthma, and 62% were polysensitized. Adverse reactions (ADRs) reported in more than 10% of actively treated subjects were mild or moderate application-site reactions, for example, oral pruritus 25% (placebo 4%) and throat irritation 21% (placebo 3%). These generally occurred during the first week of treatment and decreased over time. They led to discontinuation in less than 2.5% of subjects. None of the 3 serious ADRs were reports of anaphylaxis. No notable differences were detected in terms of incidence, nature, and severity of ADRs between adult and pediatric populations, nor between subjects with or without asthma.

CONCLUSIONS:

The pooled analysis in 1,514 subjects from 8 clinical studies demonstrates that the 5-grass pollen sublingual tablet has a similar good safety profile in adult and pediatric patients with or without mild, intermittent asthma.

01 Feb 2017·Allergo journal international

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

Article

Author: Brüggenjürgen, Bernd ; Reinhold, Thomas

BACKGROUND:

Whereas 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.

METHODS:

The 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.

RESULTS:

With 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).

DISCUSSION:

SIT 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.

100 Deals associated with Grass pollen allergy immunotherapy(Stallergenes Greer Ltd.)

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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	DE	-	01 Sep 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypersensitivity	Phase 3	FR	Lundbeckfonden	10 May 2021
Hypersensitivity	Phase 3	LV	Lundbeckfonden	10 May 2021
Hypersensitivity	Phase 3	PL	Lundbeckfonden	10 May 2021
House dust mite allergy	Phase 3	-	Stallergenes Greer Ltd.	01 Oct 2007
Rhinitis, Allergic	Phase 3	-	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)	mduvfuggrw(urfkxexktm) = wkwjnaxbsl btzlyntfxz (kwunychrxq, hykeeycnsi - bpnyqparpc) View more	-	19 May 2016
				500 IR house dust mites allergen extract tablet (500 IR)	mduvfuggrw(urfkxexktm) = depindtznr btzlyntfxz (kwunychrxq, ytqwzoxcso - mxjnhlwxch) View more
ERS2012	Not Applicable	Asthma \| Anaphylaxis	581	300IR tablet	knpzbzkdjq(ejbxoryjzw) = vraqsqbtla npyoagtywt (knejthorww )	-	01 Sep 2012
AAAAI2012	Not Applicable	Allergic rhinoconjunctivitis	633	300 IR sublingual tablet of 5-grass pollen allergen extract	arcxacemox(cpcddiailu) = ylkctftser jbvlkqyigs (lttyxabzbi )	-	01 Feb 2012
				Placebo	arcxacemox(cpcddiailu) = wihwejdeoj jbvlkqyigs (lttyxabzbi )
AAAAI2009	Not Applicable	Adrenocortical Carcinoma	89	300IR SLIT tablets	ghwhsuwuit(vxthtrfsgp): difference of adjusted means = -1.97 (95% CI, -2.99 to -0.94), P-Value = 0.0003	Positive	14 Mar 2009
				Placebo