France-based Stallergenes has secured US Food and Drug Administration (FDA) approval for its immunotherapy tablet Oralair for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.
Oralair is a combination of five grass allergen extracts, comprising Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. It is the first immunotherapy tablet to be available in the US for grass pollen allergy.
So far, allergen immunotherapy has been administered via a series of subcutaneous injections in the allergy specialist’s office and the approval provides an additional treatment option for allergy specialists and their patients.
In the US, grass allergy is the most common seasonal allergy and most people are allergic to more than one type of grass.
The drug is indicated as immunotherapy for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in-vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in the tablet.
A fast-dissolving tablet to be placed under the tongue, Oralair is approved for use in people aged between ten and 65.
According to the company, the first dose of Oralair is taken under medical supervision, and subsequent doses are administered once a day by the patient or their caregiver.
Treatment with Oralair should be started four months before the expected onset of each grass pollen season and continued throughout it.
Stallergenes chief executive officer Christian Chavy said: "This approval is a major milestone for Stallergenes. The company not only developed Oralair but it also continues to expand the frontiers of allergen immunotherapy.
"We look forward to launching Oralair with our partner, Greer, a leader in the US allergen immunotherapy market with strong and long-standing relationships with allergy specialists."
With Oralair, US allergy specialists will now be able to provide a valuable treatment alternative to their patients with grass pollen-induced allergy, including those likely to refuse or prematurely discontinue subcutaneous immunotherapy.
In October 2013, Greer and Stallergenes have signed an exclusive agreement for US commercialisation rights to Oralair.
Under that deal, Greer was responsible to lead the sales and marketing efforts for Oralair in the US and STALLERGENES will be responsible for tablet production and supply.
Approval of Oralair triggers a milestone payment from Greer to Stallergenes of $10m, which amount will be capitalised and recognised as revenue over the life of such agreement.
Under such an agreement Stallergenes will receive payments on the occurrence of regulatory and commercial milestone events totalling $120m, plus royalties and a transfer price.
Image: Pollen grains from a variety of common plants can cause hay fever. Photo: courtesy of Dartmouth Electron Microscope Facility, Dartmouth College.