The first allergen immunotherapy product for the treatment of allergies against the common ragweed has been authorised in Germany and eight other European member states since February 2018. Germany (PEI) acted as reference member state in the decentralised European marketing authorisation procedure and the Division of Allergology of the Paul-Ehrlich-Institut (PEI) performed the assessment.
Ragweed
PEI had the administrative responsibility and prepared the assessment report (AR) summarizing the characteristics of RAGWIZAX and PEI assessed the efficacy, safety, and quality of the allergen immunotherapy product. The risk/benefit ratio turned out to be favourable. Clinical studies in adults (18-50 years) provided evidence for its efficacy. In a subsequent 90-day marketing authorisation procedure, the concerned member states were given the opportunity to clarify open questions with the PEI and the pharmaceutical company.
The allergen immunotherapy product is dissolved under the tongue (sublingually) and is indicated for the treatment of allergic rhinitis and conjunctivitis caused by ragweed pollen which persist in spite of the use of medicines designed to alleviate the symptoms.
Ragweed pollen presents a very aggressive allergen. Reinforced by changes in the climate, this plant, which originates from North America, is spreading to major parts of Europe. An allergen immunotherapy product for the treatment of allergies against this plant has so far been available only as an untested personalised preparation.
Updated: 26.02.2018
