Drugs / Grazax
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | GRAZAX | ragweed sensitivity | 2015-11-12 | “GRAZAX ® has been filed for approval in Russia.” alk.net ↗ |
| Filed | Other | GRAZAX | ragweed sensitivity | 2011-08-16 | “ALK's partner in the USA, Merck, submitted a registration application for GRAZAX® in Canada.” alk.net ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04502966 | Nov 2020 → Feb 2025 | seasonal allergic rhinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 33 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT00773240 | Apr → Oct 2008 | seasonal allergic rhinitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT00421655 | Dec 2006 → Aug 2007 | allergic disease | ALK-Abelló A/S | Completed | Missed primary |
| Phase 3 | NCT00227279 | Oct 2004 → Sep 2009 | allergic disease | ALK-Abelló A/S | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT02437786 | Sep 2009 → Dec 2014 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 4 | NCT01433510 | Nov 2007 → Oct 2010 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT02005627 Comparator | Sep 2013 → Mar 2017 | allergic rhinitis | Imperial College London | Completed | No outcome recorded |
| Phase 2/3 | NCT06061848 Comparator | Feb 2023 → Dec 2030 expected | seasonal allergic rhinitis | Lars Olaf Cardell | Recruiting | No outcome recorded |
| Phase 3 | NCT01061203 Comparator | Jan 2010 → Sep 2015 | allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT01740284 Comparator | Sep 2008 → Jan 2009 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 4 | NCT01854736 Comparator | Apr 2013 → Dec 2015 | seasonal allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| — | NCT01889875 Comparator | Nov 2010 → Aug 2012 | seasonal allergic rhinitis | Bispebjerg Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2016-06-13 | ALK-Abelló A/S | Results New data from GAP landmark trial confirms GRAZAX® prevents asthma symptoms in children alk.net ↗
The data, presented at the 2016 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, confirms that GRAZAX ® can prevent asthma symptoms, as well as offering sustained relief from grass allergy symptoms. |
| 2016-01-14 | ALK-Abelló A/S | Results ALK announces top-line results from the five-year landmark GRAZAX® Asthma Prevention (GAP) trial in children alk.net ↗
The trial demonstrated that GRAZAX ® treatment significantly reduced the proportion of children experiencing asthma symptoms or using asthma medication. |
| 2014-04-14 | ALK-Abelló A/S | Regulatory ALK announces FDA approval for Merck's grass sublingual allergy immunotherapy tablet GRASTEK® (GRAZAX®) alk.net ↗ |
| 2013-12-12 | ALK-Abelló A/S | Regulatory FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX®) alk.net ↗ |
| 2013-11-09 | ALK-Abelló A/S | Results ALK's partner in North America, Merck, reports Phase III data on investigational grass sublingual allergy immunotherapy tablet alk.net ↗
The trial met its primary endpoint |
| 2013-09-04 | ALK-Abelló A/S | Regulatory ALK announces FDA Advisory Committee to review Grass AIT tablet alk.net ↗
ALK (OMX: ALK B) today announced that the US Food and Drug Administration (FDA) has scheduled an FDA Allergenic Products Advisory Committee meeting to be held on 6 November 2013 to discuss the Biologic License Application (BLA) for the investigational grass allergy immunotherapy (AIT) tablet. |
| 2013-03-27 | ALK-Abelló A/S | Regulatory License application for grass allergy immunotherapy tablet accepted for review by FDA alk.net ↗
ALK's partner for North America, Merck (known as MSD outside the USA and Canada), today announced that the Biologics License Application (BLA) for its investigational grass allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). |
| 2013-02-01 | ALK-Abelló A/S | Regulatory ALK's partner, Merck, submits a BLA to the FDA for a marketing authorisation for grass AIT (GRAZAX® in Europe) alk.net ↗ |
| 2012-10-23 | ALK-Abelló A/S | Results North American Phase III trial with grass allergy immunotherapy tablet meets primary endpoint. FDA filing remains planned for 2013 alk.net ↗ |
| 2012-03-02 | ALK-Abelló A/S | Results ALK: GRAZAX® long-term trial highlighted as editor's choice in leading scientific journal alk.net ↗
The trial is the only published large double-blind placebo-controlled trial to demonstrate that grass allergy immunotherapy tablets (AIT) is an efficacious treatment for grass pollen induced allergic rhinitis with sustained effect for at least two years after treatment completion. |
| 2011-06-30 | ALK-Abelló A/S | Regulatory ALK updates on progress in partnership with Merck in North America alk.net ↗
Merck has informed ALK that it has submitted a registration application (NDS) for the Grass Allergy Immunotherapy Tablet ( AIT) in Canada. |
| 2011-04-18 | ALK-Abelló A/S | Regulatory GRAZAX® granted reimbursement in Denmark alk.net ↗
ALK announces that the Danish Medicines Agency has decided to grant general reimbursement to GRAZAX ® as of 2 May 2011. |
| 2009-11-02 | ALK-Abelló A/S | Results GRAZAX® trial in the US meets primary endpoint alk.net ↗
The study met its primary endpoint. |
| 2009-09-26 | ALK-Abelló A/S | Regulatory GRAZAX® approved as a disease modifying allergy treatment alk.net ↗
Authorities in 27 European countries have approved GRAZAX® as a disease modifying allergy treatment. |
| 2009-06-08 | ALK-Abelló A/S | Results Improved quality of life and sustained symptom control of GRAZAX® after completion of treatment (EAACI 2009) alk.net ↗
During the first year after treatment, GRAZAX® continues to provide significant reductions in both hay fever symptoms and the patients' use of symptomatic medication. |
| 2008-11-21 | ALK-Abelló A/S | Regulatory ALK achieves general reimbursement for GRAZAX® in Spain alk.net ↗
GRAZAX® will now be eligible for general, national reimbursement on level with other pharmaceutical products in Spain. |
| 2008-11-20 | ALK-Abelló A/S | Regulatory GRAZAX® approved in Europe for treatment of children alk.net ↗
Authorities in 27 European countries have approved ALK's tablet-based vaccine against grass pollen allergy, GRAZAX®, for treatment of children and adolescents (5 - 17 years old) suffering from grass pollen induced hay fever. |
| 2008-10-22 | ALK-Abelló A/S | Results Persistent vaccination effect of GRAZAX® after completion of treatment alk.net ↗
During the first year after completion of treatment, GRAZAX® continues to provide statistically significant reductions in both hay fever symptoms and the use of symptom-relieving medication. |
| 2008-03-01 | ALK-Abelló A/S | Results ALK-Abelló announces positive third year results from clinical study with GRAZAX® alk.net ↗
Today, ALK-Abelló announces positive results from the third treatment year of the GT-08 study with GRAZAX®, the company's tablet-based vaccine against grass pollen allergy. |
| 2007-11-22 | ALK-Abelló A/S | Results Favourable results from GRAZAX® study in children alk.net ↗
The study met its primary endpoint and showed a statistically significant clinical effect corresponding to the results from the comprehensive European clinical development program in adult patients. |
| 2007-03-05 | ALK-Abelló A/S | Regulatory ALK-Abelló launches GRAZAX® in Sweden as a therapy eligible for full reimbursement alk.net ↗
The Swedish Pharmaceutical Benefits Board has approved GRAZAX®, ALK-Abelló’s tablet-based vaccine against grass pollen allergy, for full reimbursement. |
| 2006-12-21 | ALK-Abelló A/S | Results ALK-Abelló, positive second year results from clinical study with Grazax alk.net ↗
ALK-Abelló announces second-year results from clinical study with GRAZAX® showing improved effect in the second treatment season. |
| 2006-09-25 | ALK-Abelló A/S | Regulatory ALK-Abelló, Grazax® approved in Europe alk.net ↗
Authorities in 27 European countries have now approved GRAZAX®, ALK-Abelló's tablet-based vaccine against grass pollen allergy. |
| 2006-03-14 | ALK-Abelló A/S | Regulatory ALK-Abelló, Grazax approved in Sweden alk.net ↗
The Swedish Medical Products Agency has approved ALK-Abelló' A/S' tablet-based immunotherapy, GRAZAX®, for the treatment of grass pollen allergy. |
All press releases naming this drug 30 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Grazax | “the efficacy of a rapidly dissolving grass allergen tablet (GRAZAX, ALK-Abelló, Hørsholm, Denmark) compared with placebo” PMID 16890769 ↗ Aug 200612“Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy.” PMID 17620076 ↗ Aug 2007 |
| Known as | Phleum Pratense grass pollen allergen extract | “1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T” NCT01740284 ↗ |
| Modality | Other / unclassified | “a rapidly dissolving grass allergen tablet” PMID 16890769 ↗ Aug 2006 |
| Route | Oral | “oral lyophilisate” PMID 23725348 ↗ Jun 2013 |