Drugs / HDM SLIT-tablet
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | — | 2015-08-18 | “A regulatory filing for the HDM SLIT-tablet has been submitted in Australia by bioCSL.” alk.net ↗ authority 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 via...” alk.net ↗ |
| Filed | US (FDA) | — | — | — | “as well as the submission of a U.S. FDA Biologics License Application for the HDM SLIT-tablet, known as ACARIZAX ® in Europe.” alk.net ↗ “HDM SLIT-tablet Submitted (Feb 2016 U.S. FDA BLA) Possible approval in 2017” alk.net ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03654976 | Feb 2018 → May 2022 | allergic asthma, allergic rhinitis | ALK-Abelló A/S | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-05-04 | ALK-Abelló A/S | ALK's HDM SLIT-tablet, ACARIZAX®, approved in Canada alk.net ↗ |
| 2016-04-27 | ALK-Abelló A/S | 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 ↗ |
| 2015-06-10 | ALK-Abelló A/S | ALK’s partner, MSD, publishes Phase II data on house dust mite SLIT-tablet in leading allergy journal journal alk.net ↗ |
| 2015-06-04 | ALK-Abelló A/S | ALK announces top-line results from its partner MSD's North American Phase III trial of house dust mite SLIT-tablet alk.net ↗ |
| 2015-01-26 | ALK-Abelló A/S | ALK's partner, Torii, submits registration application for the house dust mite SLIT-tablet in Japan alk.net ↗ |
| 2014-11-20 | ALK-Abelló A/S | ALK submits registration application for house dust mite SLIT-tablet in Europe alk.net ↗ |
| 2014-06-09 | ALK-Abelló A/S | ALK presents Phase III data on house dust mite SLIT-tablet at EAACI Annual Congress in Copenhagen alk.net ↗ |
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 NCT03654976 ↗ |