Stallergenes has been granted European approval to market Oralair in both adults and children through a Mutual Recognition Procedure. Germany, the first country where Oralair has been marketed, was the reference Member state.
Oralair is now registered in Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain. All the countries in which Stallergenes filed its application have approved it.
Oralair is an immunotherapy tablet aimed at patients suffering from severe rhinoconjunctivitis caused by grass pollens, inadequately controlled using symptomatic treatments (antihistamines, corticosteroids).
“The European registration of Oralair is a major milestone for Stallergenes. It confirms the evolution of immunotherapy towards EBM-documented, well-tolerated treatments, effective from the very first season. Immunotherapy tablets now share the same level of recognition as conventional pharmaceuticals and form a new therapeutic class: allergens. The next step is to implement the price and reimbursement assessment procedures prior to the launch country by country,” said Albert Saporta, chairman and CEO of Stallergenes.