Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) told investors it has received marketing authorisation in Germany for Grassmuno, its grass pollen immunotherapy.
The approval was granted by the Paul Ehrlich Institut under the Therapieallergene-Verordnung framework.
Grassmuno is a subcutaneous immunotherapy designed to treat moderate to severe allergic rhinoconjunctivitis caused by grass pollen. The treatment is delivered as a six-injection pre-seasonal course.
"The regulatory approval of this state-of-the-art short-course aluminium-free immunotherapy is a defining moment for Allergy Therapeutics and for the future of allergy immunotherapy in Germany," chief executive Manuel Llobet said in Tuesday's statement.
"Grass pollen, a common cause of seasonal allergy, significantly impacts the lives of many people and new treatment options are desperately needed."
Llobet added: "Grassmuno offers an effective, convenient treatment option for people living with a grass-pollen allergy, and its authorisation under the TAV regulation validates our clinical excellence and commitment to quality. It also validates our MATA MPL platform concept and establishes a strong foundation for our future expansion strategy for this innovative and disruptive immunotherapy with allergens such as birch and ragweed across other major global markets."