Date: 2013-02-21
Type of information:
Product name: Oralair®
Compound: allergen immunotherapy sublingual tablet consisting of five purified and calibrated pollen extracts
Therapeutic area:
Action mechanism: Oralair® is an allergen immunotherapy sublingual tablet consisting of five purified and calibrated pollen extracts: Perennial Ryegrass (Lolium perenne), Kentucky Bluegrass (Poa pratensis), Timothy Grass (Phleum pratense), Orchard Grass (Dactylis glomerata) and Sweet Vernal Grass (Anthoxanthum odoratum).
To date, Oralair is available in 16 European countries and also continues to expand beyond Europe: following a positive start in Australia/New Zealand and Russia, the product was launched a few months ago in Canada, which makes it the first allergen immunotherapy tablet to be registered and marketed in North America.
Company: Stallergenes (France)
Disease: allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens
Latest news: * On April 2, 2014, the FDA has announced it has approved first sublingual allergen extract for the treatment of certain grass pollen allergies. Oralair® is approved to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair® is the first sublingual allergen extract approved in the United States. It contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy. The safety and effectiveness of Oralair® was evaluated in studies in the United States and Europe, involving approximately 2,500 people. To assess the effectiveness, patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one grass pollen season, patients taking Oralair® experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo. The prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Oralair also has a medication guide for distribution to the patient. The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.
* On February 18, 2013, Stallergenes has announced that the FDA has accepted for review its Biologics License Application (BLA) for Oralair®, its 5-grass pollen extract allergen immunotherapy (AIT) sublingual tablet. This BLA filing positions Stallergenes as the first pharmaceutical company to file and have FDA acceptance to review a BLA for an AIT sublingual tablet in this market. The product is marketed in Europe since 2008. The application pending at FDA is based on results from an extensive clinical development program. Oralair® has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 1,500 adults and children. Positive results were achieved in these trials designed to demonstrate that pre-seasonal and co-seasonal treatment with grass allergy immunotherapy reduces patients’ allergy symptoms and their need for symptom-relieving medication and provides a sustained long-term effect after completion of treatment. Oralair® was generally well tolerated and the most common treatment-emergent adverse events (greater than 10%) were application site reactions including oral pruritus and throat irritation.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-04-02
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
