Drug for Dust Mite Allergy Approved by FDA

Good news for house dust mite allergy sufferers: the FDA has approved Merck, Sharp & Dohme Corp.’s Odactra to treat allergic rhinitis and conjunctivitis in patients between the ages of 18 and 65. The allergen extract is the first of its kind to be administered sublingually.

“House dust mite allergic disease can negatively impact a person’s quality of life,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”

Dust mites are microscopic insects which are commonly found in soft furnishings – like carpets, bedding and other furniture – in the home. Symptoms of a dust mite allergy include a runny nose, cough, nasal congestion and watery eyes.

Odactra uses allergen immunotherapy to expose patients to dust mite allergens. By introducing a small amount of these allergens to the immune system on a regular basis, the hope is that the symptoms of the allergy will gradually be reduced.

The drug is taken once-per-day in a dissolvable pill placed under the tongue. Patients take their first dose of Odactra in the presence of a physician in the event that the drug triggers any adverse reactions. Eight to 14 weeks of daily dosing may be necessary before a patient begins to see an improvement in their allergy symptoms.

Multiple clinical trials involving approximately 2,500 participants in Canada, the US and Europe were conducted to assess the safety and efficacy of Odactra. In these trials, patients taking Odactra saw a 16 to 18 percent reduction in their allergy systems and the need to take antihistamines, compared to patients given a placebo.

As a condition of the approval, the FDA is requiring that the drug carry a boxed warning to alert prescribing physicians and patients to the risk of serious, potentially-fatal, allergic reactions. The FDA also requires the patients taking Odactra be prescribed an epinephrine auto-injector in case of adverse reactions.