The US Food and Drug Administration (FDA) approved Paris-based Stallergenes' Oralair for grass pollen–induced allergic rhinitis on April 1, making it the first oral immunotherapy to reach the US market. Oralair is an under-the-tongue tablet containing a mix of five standardized grass allergens—perennial rye grass, meadow grass, timothy grass, cocksfoot and sweet vernal grass—that mimics patients' natural exposure during the pollen season. Currently, allergy immunotherapies involve 3–5 years of subcutaneous injections. “A sublingual tablet does allow an increased convenience factor,” says Sandra Lin, an associate professor of otolaryngology, Johns Hopkins School of Medicine, Baltimore. Still, initial uptake of Oralair may be slow. Jacoba van der Gaag, lead analyst at Datamonitor Healthcare, London, says the biggest barrier is getting the patient to consider immunotherapy in the first place, as symptomatic relief can be easily achieved with over-the-counter medicines, such as antihistamines. Oralair, approved in the EU and Canada, netted Stallergenes €22.2 ($30.7) million in 2013. Also approved by FDA on April 15 is Merck's Grastek, another sublingual immunotherapy, composed of a single grass pollen extract (timothy grass). Grastek is currently sold in Europe as Grazax. Stallergenes has two other oral allergy immunotherapies in late-stage development: Actair, in collaboration with Shionogi of Osaka, Japan, for dust mite–related allergic rhinitis, and Oralair Birch, a recombinant protein synthesized from the DNA-coding region of Betv1a, the major birch pollen allergen, in phase 3.
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Tse, M. Oral immunotherapy approved. Nat Biotechnol 32, 405 (2014). https://doi.org/10.1038/nbt0514-405c