Drugs / HDM SLIT-tablet
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed allergic rhinitis 1 milestone | |||||
| Filed | Other | — | allergic rhinitis | 2024-06-03 | “ALK has submitted a regulatory filing of the HDM SLIT-tablet in younger children (5-11 years) for review by relevant health authorities.” alk.net ↗ |
| Filed Indication not stated 3 milestones | |||||
| Filed | Other | — | — | 2015-08-18 | “A regulatory filing for the HDM SLIT-tablet has been submitted in Australia by bioCSL.” alk.net ↗ |
| Filed | EU (EMA) | — | — | 2014-11-20 | “Today, ALK's regulatory filing for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet has been accepted for review by the European health authorities” alk.net ↗ |
| Filed | US (FDA) | — | — | — | “HDM SLIT-tablet Submitted (Feb 2016 U.S. FDA BLA)” alk.net ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04541004 | Sep 2020 → Apr 2021 | allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-06-03 | ALK-Abelló A/S | Results ALK presents positive phase 3 paediatric trial data offering new hope for children with respiratory allergies alk.net ↗
ALK presented new data from two paediatric phase 3 clinical trials evaluating SQ sublingual immunotherapy (SLIT) tablets in house dust mite (HDM) and tree pollen respiratory allergy. |
| 2019-02-26 | ALK-Abelló A/S | Results New data shows ALK’s house dust mite SLIT-tablet significantly improves quality of sleep for allergic rhinitis patients alk.net ↗
Approximately 9 out of 10 trial subjects with 'moderately or severely affected sleep' saw an improvement following treatment with ALK’s HDM SLIT-tablet. |
| 2016-04-27 | ALK-Abelló A/S | Results Journal of the American Medical Association publishes Phase III data from allergic asthma trial with ALK's house dust mite SLIT-tablet, ACARIZAX® alk.net ↗
The results appear in the latest edition of JAMA. |
| 2016-01-27 | ALK-Abelló A/S | Regulatory Marketing authorisation for ACARIZAX® issued in France alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that authorities in France, the world's biggest sublingual allergy immunotherapy market, have issued a marketing authorisation for ALK's new house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet), ACARIZAX ® . |
| 2015-09-28 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, obtains approval for the house dust mite SLIT-tablet in Japan alk.net ↗
ALK today announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet MITICURE™. |
| 2015-08-31 | ALK-Abelló A/S | Regulatory ALK obtains European approval for its house dust mite sublingual allergy immunotherapy tablet against allergic rhinitis and allergic asthma alk.net ↗ |
| 2015-06-10 | ALK-Abelló A/S | Results ALK’s partner, MSD, publishes Phase II data on house dust mite SLIT-tablet in leading allergy journal journal alk.net ↗
By week 24, patients reported that the higher 12 DU dose HDM SLIT-tablet improved nose symptoms by 49%, and eye symptoms by 68%, compared with placebo. |
| 2015-06-04 | ALK-Abelló A/S | Results ALK announces top-line results from its partner MSD's North American Phase III trial of house dust mite SLIT-tablet alk.net ↗
The trial demonstrated a statistically significant improvement in the primary endpoint in favour of HDM SLIT-tablet compared with placebo. |
| 2015-01-26 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, submits registration application for the house dust mite 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 ALK's house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet). |
| 2014-11-20 | ALK-Abelló A/S | Regulatory ALK submits registration application for house dust mite SLIT-tablet in Europe alk.net ↗
ALK's regulatory filing for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet has been accepted for review by the European health authorities via the Decentralised Procedure with Germany as the Reference Member State. |
| 2014-06-09 | ALK-Abelló A/S | Results ALK presents Phase III data on house dust mite SLIT-tablet at EAACI Annual Congress in Copenhagen alk.net ↗
Today, ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) has presented key trial results on its new sublingual allergy immunotherapy tablet (SLIT-tablet) for house dust mite (HDM) respiratory allergic diseases at the 2014 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI), in Copenhagen, Denmark. |
All press releases naming this drug 12 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 | HDM SLIT-tablet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04541004 ↗ |