Germany Approves Groundbreaking Grass Pollen Allergy Immunotherapy for 2026 Launch

Germany's Paul-Ehrlich-Institut (PEI) has approved Grassmuno, a new subcutaneous immunotherapy for grass pollen allergies. The treatment, developed by Allergy Therapeutics, is the first of its kind to meet the strict requirements under Germany's Therapieallergene-Verordnung (TAV).

The therapy contains extracts from 13 grass pollens, chemically modified into allergoids. It also includes two adjuvants: microcrystalline tyrosine (MCT) and monophosphoryl lipid A (MPL). Unlike traditional treatments, Grassmuno is aluminium-free and follows a short-course schedule of six injections before pollen season begins.

Approval came after the Phase III G306 trial showed a clear reduction in allergy symptoms and medication use compared to a placebo. The study was stopped early due to strong positive results during an interim analysis.

Grassmuno is intended for adults with moderate to severe grass pollen allergies, including those with well-controlled asthma. The product is set to launch in the first quarter of 2026, becoming the first TAV-approved subcutaneous grass pollen immunotherapy available in Germany.

The approval marks a milestone for allergy treatments in Germany. Grassmuno offers a new option for patients with severe grass pollen allergies, including those managing asthma. Its launch in early 2026 will provide an alternative to existing therapies.