Drugs / Sublingual allergy immunotherapy tablet
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn house allergic alveolitis 3 milestones | |||||
| Withdrawn | China (NMPA) | — | house allergic alveolitis | 2024-06-21 | “decided to withdraw the Biologic License Application (‘BLA’) for its house dust mite (‘HDM’) sublingual allergy immunotherapy tablet in China.” alk.net ↗ |
| Filed | US (FDA) | — | house allergic alveolitis | 2016-02-10 | “has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its house dust mite (HDM) sublingual allergy immunotherapy tablet” alk.net ↗ |
| Filed | EU (EMA) | — | house allergic alveolitis | 2014-11-20 | “a registration application for the house dust mite sublingual allergy immunotherapy tablet has been submitted in Europe.” alk.net ↗ |
| Filed allergic rhinitis 2 milestones | |||||
| Filed | Japan (PMDA) | — | allergic rhinitis | 2015-12-25 | “submitted a New Drug Application in Japan for the Japanese cedar pollen sublingual allergy immunotherapy tablet for the indication of allergic rhinitis (hay fever).” alk.net ↗ |
| Filed | Japan (PMDA) | — | allergic rhinitis | 2015-01-26 | “has submitted a New Drug Application in Japan for ALK's house dust mite sublingual allergy immunotherapy tablet for the indication of allergic rhinitis.” alk.net ↗ |
| Filed ragweed sensitivity 1 milestone | |||||
| Filed | US (FDA) | RAGWITEK | ragweed sensitivity | — | “submitted the BLA to the FDA for the investigational sublingual tablet against ragweed allergy, which has the proposed trade name of RAGWITEK ™ .” alk.net ↗ “submitted the BLA to the FDA for the sublingual allergy immunotherapy tablet against ragweed allergy.” alk.net ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04145219 | Oct 2019 → Apr 2023 | allergic rhinitis | ALK-Abelló A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | ALK-Abelló A/S | Results ALK presented comprehensive data on two new paediatric AIT tablets and a nasal adrenaline spray at EAACI 2025 alk.net ↗
The evidence demonstrated that the treatment option can transform allergy care in suitably informed patients and families. |
| 2025-05-08 | ALK-Abelló A/S | Regulatory ITULATEK® approved for treatment of children and adolescents in Canada alk.net ↗
ALK ( ALKB:DC / OMX: ALK B ) today announced that Health Canada has approved ALK’s regulatory filing for ITULATEK ® (tree pollen sublingual allergy immunotherapy tablet) for treatment of children and adolescents aged five to 17. |
| 2025-04-23 | ALK-Abelló A/S | Regulatory ITULAZAX® tree pollen tablet approved for treatment of children in Europe alk.net ↗
ALK (ALKB.DC / OMX: ALK B) today announced that its European regulatory filing for ITULAZAX ® (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents aged five to 17 has been approved by the health authorities in 17 EU countries via a type II variation procedure. |
| 2024-06-21 | ALK-Abelló A/S | Regulatory ALK provides update on regulatory process for the house dust mite allergy tablet in China alk.net ↗
ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that it has decided to withdraw the Biologic License Application (‘BLA’) for its house dust mite (‘HDM’) sublingual allergy immunotherapy tablet in China. |
| 2015-12-25 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, submits registration application for the cedar SLIT-tablet in Japan alk.net ↗
ALK's partner for Japan, Torii Pharmaceutical Co. Ltd., has submitted a registration application — a New Drug Application (NDA) — to the Japanese Ministry of Health, Labour and Welfare (MHLW), for the Japanese cedar pollen sublingual allergy immunotherapy tablet (SLIT-tablet). |
| 2015-08-07 | ALK-Abelló A/S | Results ALK's partner for Japan reports positive Phase II/III trial results for Japanese Cedar SLIT-tablet alk.net ↗ |
| 2014-06-16 | ALK-Abelló A/S | Results ALK's partner for Japan announces trial results for house dust mite SLIT-tablet alk.net ↗
A parallel trial, investigating the safety and efficacy in HDM-induced allergic rhinitis was successfully completed in March 2014 and met its primary efficacy endpoint. |
| 2014-05-15 | ALK-Abelló A/S | Regulatory ALK's partner for North America, Merck, announces launch of RAGWITEK™ in Canada alk.net ↗
The launch announcement follows regulatory approval from the Canadian authorities of the New Drug Submission (NDS). |
| 2014-03-10 | ALK-Abelló A/S | Results ALK's partner for Japan reports positive trial results for house dust mite SLIT-tablet alk.net ↗ |
| 2014-01-28 | ALK-Abelló A/S | Regulatory FDA Advisory Committee recommends approval of ragweed sublingual allergy immunotherapy tablet alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) has voted that the available data support the efficacy and safety of Merck's RAGWITEK ™ . |
| 2013-12-26 | ALK-Abelló A/S | Regulatory ALK announces FDA Advisory Committee to review ragweed sublingual AIT tablet alk.net ↗ |
| 2013-12-12 | ALK-Abelló A/S | Regulatory FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX®) alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) has voted unanimously that the available data support the efficacy and safety of Merck's GRASTEK TM in patients aged five to 65 years. |
| 2009-11-02 | ALK-Abelló A/S | Results GRAZAX® trial in the US meets primary endpoint alk.net ↗
The investigational sublingual allergy immunotherapy tablet (GRAZAX®) meets primary endpoint in a study of adult subjects with a history of grass pollen allergies. |
All press releases naming this drug 19 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sublingual allergy immunotherapy tablet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04145219 ↗ |