HAL Allergy first company to achieve marketing authorisations in line with Therapieallergene Verordnung (TAV)
HAL Allergy announced the registration of SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml in Germany. These are the first marketing authorisations granted by the Paul Ehrlich Institute following the German Therapieallergene‑Verordnung (TAV).
The TAV was initiated by the German Federal Ministry of Health on 14 November, 2008, and regulates the marketing authorisation requirements for frequent therapeutic allergens, in order to guarantee quality, effectiveness and safety.
“We are proud to be the first company that registers two products in line with the German Therapieallergene‑Verordnung”, says Harry Flore, CEO of HAL Allergy Group. “We acknowledge that the regulations set by the German authorities, are important for allergic patients in Germany, the largest European allergy market. Therefore, we were determined to register our sublingual birch and trees products. The studies to obtain these marketing authorisations are part of our extensive clinical development program and follow the new EMA requirements.”
The studies confirm that SUBLIVAC® Birch 40.000 AUN/ml shows significant and clinically relevant improvement for adults in all primary and secondary endpoints versus placebo.
Principal investigator Prof. Dr. Oliver Pfaar, Scientific Head at the Allergy Center Wiesbaden and Professor at the Medical Faculty Mannheim, University Heidelberg, Germany, also member of the Scientific Advisory Board of HAL Allergy Group explains: “In the phase II study we identified the optimal dose of allergen. Phase III demonstrated a strong clinical efficacy of 32% in the combined symptom and medication score, compared to placebo. There was a significant improvement in quality of life scores as well as important changes in immunoglobulins.”