Allergy Therapeutics Secures First German Approval for Grassmuno Grass Pollen Immunotherapy
核心洞察
Allergy Therapeutics (搜索) received marketing authorization from Germany's Paul Ehrlich Institut (搜索) for Grassmuno (搜索), marking the first subcutaneous grass pollen immunotherapy approved under the TAV regulatory framework.
The treatment offers a convenient six-injection pre-seasonal course that demonstrated statistically significant reduction in allergy symptoms compared to placebo in Phase III trials.
Commercial launch is planned for Q1 2026 in Germany's seasonal allergy market, projected to reach approximately $1 billion by 2030.
Allergy Therapeutics (搜索) has achieved a regulatory milestone with the German approval of Grassmuno (搜索) (Grass MATA MPL), a subcutaneous immunotherapy for grass pollen allergies. The Paul Ehrlich Institut (搜索) (PEI) granted marketing authorization for the treatment, making it the first subcutaneous grass pollen immunotherapy approved under Germany's stringent TAV (Therapieallergene-Verordnung) framework.
Innovative Treatment Approach
Grassmuno (搜索) represents a significant advancement in allergy immunotherapy, offering a six-injection pre-seasonal course administered before the grass pollen season begins. The treatment contains a unique mixture of allergen extracts from 13 grass pollens, modified with glutaraldehyde to form allergoids that reduce reactivity with immunoglobulin E (IgE (搜索)) antibodies while maintaining important immunological properties such as T-cell reactivity.
The immunotherapy incorporates Allergy Therapeutics (搜索)' proprietary adjuvant system, combining monophosphoryl lipid-A (MPL) and microcrystalline tyrosine (MCT). This combination enhances the immunogenic effect and promotes a shift from allergen-specific helper T-cell Type 2 (Th2 (搜索)) to helper T-cell Type 1 (Th1 (搜索)) immune responses.
Clinical Evidence and Efficacy
The approval follows submission of a comprehensive evidence package including results from the pivotal Phase III G306 trial in adults. The study demonstrated a highly statistically significant and clinically relevant reduction in the Combined Symptom & Medication Score (CSMS) compared to placebo over the peak pollen season.
Grassmuno (搜索) is indicated for treating moderate to severe allergic symptoms in adults caused by grass pollen, including rhinitis and allergic conjunctivitis, in patients without asthma or with well-controlled asthma.
Market Position and Commercial Strategy
The approval positions Allergy Therapeutics (搜索) advantageously in Germany, currently its largest market. The TAV framework requires allergy immunotherapies to meet the same regulatory standards as other prescription medicines, with older products losing transitional period protection next year.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics (搜索), described the approval as "a defining moment for Allergy Therapeutics and for the future of allergy immunotherapy in Germany." He emphasized that the treatment offers "an effective, convenient treatment option for people living with a grass-pollen allergy" and validates the company's MATA MPL platform concept.
Future Development Plans
Allergy Therapeutics (搜索) launched a Phase III trial (G308) in November 2024 to evaluate Grassmuno (搜索)'s efficacy and safety in pediatric populations. This represents the first long-term SCIT trial in children and complements the company's adult studies.
The company plans to commercialize Grassmuno (搜索) in Germany during Q1 2026 through its subsidiary Bencard Allergie (搜索). With grass pollen representing a key segment of Germany's seasonal allergy market, projected to reach approximately $1 billion by 2030, Grassmuno is expected to become a major business driver.
Allergy Therapeutics (搜索) continues exploring registration opportunities in other major global markets, following engagement with regulatory authorities regarding local requirements. The company views this approval as establishing a foundation for expanding its platform to include other allergens such as birch and ragweed across international markets.