PARIS, November 27 /PRNewswire-FirstCall/ -- Stallergenes has been granted European approval to market Oralair(R) in both adults and children through a Mutual Recognition Procedure. Germany, the first country where Oralair(R) has been marketed, was the reference Member state.
Oralair(R) 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(R) 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(R) 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," says Albert Saporta, Chairman and CEO of Stallergenes.
The Oralair(R) active substance consists of a set of pollens corresponding to the epidemiological characteristics of patient exposure in Europe: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).
From the outset, its clinical development has taken into account the
benefit to patients: proven efficacy, safety, ease of use, compliance, and
cost-containment through a pre- and coseason
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