ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF):
- The
US Food and Drug Administration 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, involving over 1,000 children 5 through 17 years of age in
North America andEurope - This label extension advances ALK’s efforts to expand the coverage of its tablet portfolio to all relevant ages
ALK today announced that it has gained approval from the
Ragweed is a common cause of seasonal, airborne allergy in
ALK’s Executive Vice President of Research and Development,
The application for paediatric use drew upon clinical data from a Phase III safety and efficacy trial involving 1,022 patients 5 through 17 years of age with a history of ragweed-induced allergic rhinitis. The randomised, multi-centre, placebo-controlled, double-blind, comparative trial met its primary endpoint, with a major reduction in the average total combined score (TCS) during the peak ragweed season of 38%. Moreover, efficacy in children was consistent with that seen for its sister product, GRAZAX® (GRASTEK® in the
Since RAGWITEK® is already on the market in the
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014
About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm,
Attachment
- ALK_PressRelease_ALK_PaediatricApprovalForRagweed_SLIT-tabletUSA_19Apr21
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