In 2014, Stallergenes Greer sought FDA approval for Oralair, a grass pollen sublingual immunotherapy, for use in patients aged five to 65 years of age – the same age range indicated for use in Europe, where Oralair has been approved since 2008. The therapy is a once-daily tablet that rapidly dissolves under the tongue and consists of pollen extracts from five types of grass. It is taken from about four months before pollen season begins until the pollen season is over.

Despite EMA approval, the FDA did not believe there was adequate safety data for children between the ages of five and nine years old. As a result, the FDA only approved the drug for patients ten years and older and requested additional safety data on paediatric patients aged five to nine.

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At the 2018 Joint Congress of the American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO), Stallergenes Greer presented the outcomes from this post-marketing study, demonstrating that the safety profile of Oralair in five to nine year-old children was satisfactory, consistent with what had previously been observed. These data will enable a significant label expansion for the drug in the US, which will likely affect future market share for direct competitors like Merck and ALK-Abello’s Grastek.

Orolair’s paediatric safety profile

The observational study was performed in grass-pollen allergic children aged five to nine across multiple centers in Europe. Patients were followed to assess the safety and tolerability of Oralair during the first 30 days of treatment. A total of 307 children (Mean age: 7.2 years; 71% male) with grass pollen-induced allergic rhinitis (with or without conjunctivitis), were enrolled in the study.  Over the first month of treatment, 56% of patients reported adverse reactions (ADRs), most of which were mild and moderate application site reactions such as throat irritation and oral pruritus.

Most ADRs occurred early during treatment: 20% on the first day, 14% on the second day and 34% between the third and tenth days. Of the 16 patients (5.2%) who discontinued the drug due to adverse reactions, the majority (75%) discontinued within the first five days of treatment. Only two patients reported a serious ADR, both of whom recovered quickly and did not require the use of epinephrine. The study showed that over the first month of treatment with Oralair, the safety profile in children aged five to nine was consistent with what has previously been observed, both in other studies for Oralair, as well as for other sublingual immunotherapies.

The expansion of Oralair to patients aged five to nine will potentially improve market share for the drug. Lacking the approval to offer Oralair to this portion of the paediatric population has been one of the few ways that Oralair falls short of its competitor, Grastek. Otherwise, in comparison to Grastek, Oralair has a shorter treatment duration (six to eight months rather than year-round) and contains five types of grass pollen instead of just one. It is unclear when the FDA will officially approve this indication expansion for Oralair, but when it happens, it is likely to be an important event in the seasonal allergy market.

Related Reports

GlobalData (2014). Expert Insight: Merck is Second in Receiving FDA Approval for Grass Pollen Immunotherapy Tablet, April 2014, GDHC0687EI.

GlobalData (2015). PharmaPoint: Allergic Rhinitis – Global Drug Forecast and Market Analysis to 2024, August 2015, GDHC113PIDR.

GlobalData (2014). OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy – Opportunity Analysis and Forecasts to 2018, September 2014, GDHC023POA.

GlobalData (2014). OpportunityAnalyzer: Allergic Conjunctivitis – Opportunity Analysis and Forecasts to 2018, September 2014, GDHC030POA.