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Grassmuno® marketing authorisation in Germany
Allergy Therapeutics plc has received marketing authorisation from the German regulatory authority, the Paul Ehrlich Institut, for its subcutaneous grass pollen allergen immunotherapy, Grassmuno®, marking the first such approval under Germany's TAV program. This approval, based on a comprehensive package of quality, safety, and clinical efficacy data, including a significant reduction in the Combined Symptom & Medication Score in a Phase III trial, is expected to drive commercialisation in Germany in the first quarter of 2026. The German seasonal allergy market is projected to reach approximately US$1 billion by 2030, and the company is pursuing expansion strategies for Grassmuno® in other major global markets. Disclaimer*
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n\n\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or the \"Company\" or the \"Group\")\n \nAllergy Therapeutics granted marketing authorisation for Grassmuno® (Grass MATA MPL) by the German regulatory authority, the Paul Ehrlich Institut\n \n- Regulatory approval in Germany follows submission of comprehensive evidence package of quality, safety and clinical efficacy supporting innovative subcutaneous immunotherapy (SCIT) designed to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen\n- First subcutaneous grass-pollen immunotherapy approved under Germany's TAV programme\n- Commercialisation in Germany anticipated Q1 2026\n- German seasonal allergy market is projected to reach ~US$1 billion by 20301\n- Company continues its expansion strategy for the product with potential for regulatory submissions across other major global markets\n \n16 December 2025: Allergy Therapeutics plc (AIM: AGY), the integrated commercial biotechnology company specialising in allergy immunotherapies, today announces that the Paul Ehrlich Institut (PEI) has granted a marketing authorisation in Germany for the Group's subcutaneous grass pollen allergen immunotherapy, Grass MATA MPL, which will be commercialised in the German market as Grassmuno®.\n \nGrassmuno is a subcutaneous allergen immunotherapy containing a unique mixture of allergen extracts from grass pollen and the Group's novel adjuvant system, monophosphoryl lipid-A (MPL®) and the biodegradable depot adjuvant microcrystalline tyrosine (MCT), to increase the immunotherapy's immunogenic effect. It is indicated for the treatment of moderate to severe allergic symptoms in adults caused by pollen from grasses (hay fever), such as running nose (rhinitis), allergic conjunctivitis (rhinoconjunctivitis), without asthma or with asthma that is well controlled. Treatment is administered before the grass-pollen season as a six-injection pre-seasonal course.\n \nThe approval marks the first subcutaneous grass-pollen immunotherapy to be authorised by the PEI through its TAV (Therapieallergene-Verordnung) framework and follows the submission of a comprehensive evidence package of quality, safety and clinical efficacy including th...