HDM-SLIT (house dust mite sublingual allergy immunotherapy tablet) approved in the EU for allergic rhinitis and allergic asthma- ALK
ALK has obtained European approval for its HDM-SLIT (house dust mite sublingual allergy immunotherapy tablet) against allergic rhinitis and allergic asthma.
The HDM SLIT-tablet is indicated in adult patients (18–65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions:
- Persistent moderate to severe HDM allergic rhinitis despite the use of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis and where patients' asthma status has been carefully evaluated
The MITRA Phase III trial met its primary clinical endpoint – reduction in the risk of moderate-to-severe asthma exacerbation during ICS reduction as measured by the time to the first exacerbation. Patients who received the dose of 12 SQ-HDM experienced a significant improvement in their asthma control as evident by a 34% reduction in risk of suffering a moderate-to-severe asthma exacerbation during the withdrawal of inhaled corticosteroids. The MERIT trial evaluated the efficacy and safety of the HDM SLIT-tablet compared to placebo in the treatment of HDM-induced allergic rhinitis. In addition, the MERIT Phase III trial met its primary clinical endpoint – a reduction in the combined rhinitis symptom and medication score.
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