Trial Profile
A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 15 May 2022
Price :
$35
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At a glance
- Drugs Short ragweed pollen allergen extract (Ragwitek) (Primary) ; Epinephrine; Loratadine; Mometasone; Olopatadine; Salbutamol
- Indications Allergic rhinitis; Allergic rhinoconjunctivitis; Ragweed pollen hypersensitivity
- Focus Registrational; Therapeutic Use
- Sponsors Merck Sharp & Dohme
- 19 Apr 2021 According to an ALK-Abello media release, the U.S. Food and Drug Administration (FDA) approved RAGWITEK (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages five through 65.The approval was based, in part, on data from the largest Phase 3 clinical trial in children with ragweed allergic rhinitis, with or without conjunctivitis, conducted to date.
- 19 Apr 2021 According to an ALK-Abello media release, the full results were published in the peer-reviewed publication, The Journal of Allergy and Clinical Immunology
- 19 Apr 2021 According to an ALK-Abello media release, the US FDA has approved extending the current product labelling of RAGWITEK to include paediatric allergic rhinitis patients.The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials in North America and Europe.The application for paediatric use drew upon clinical data from this study.