FDA Approves First Sublingual Allergy Immunotherapy Agents

While this form of immunotherapy is new to the United States, it has been used safely in Europe for about two decades, said Dr. Sautter. Some physicians in the U.S. have also used allergy serums sublingually through off-label prescription. “The advantage of having FDA approval for these tablets means the patient receives the same dose of the medication every time in a form that is more effectively absorbed under the tongue,” he said.

The risk of anaphylaxis and throat swelling is decreased with oral immunotherapy compared with injections, which is why patients can move out of the physician’s office after the first treatment; however, all patients on oral immunotherapy are advised to have a readily accessible dose of an auto-injectable epinephrine in case a problem occurs away from the physician’s office.

Who Benefits

“For people who have more persistent seasonal allergic rhinitis but who haven’t tried injection therapy, these medications are likely to become a new form of treating allergies without shots,” said Dr. Marple. Oralair is approved for patients as young as five years old, and Grastek is approved for those aged 10 and older. “It’s ideal for pediatric patients, because children are really not big fans of having an injection every one to two weeks,” said Dr. Marple.

But not all patients benefit from oral immunotherapy, said Dr. Sautter. “What I’ve seen estimated is up to an average of 30% reduction in allergic symptoms in every patient,” he said. “Some people will derive more benefits and some will derive less. In some patients, allergy symptoms will go away completely.”

Oral immunotherapy is not recommended for patients with severe, unstable, or uncontrolled asthma, those who may have certain underlying medical conditions that are not compatible with severe allergic reactions, those who may be allergic to the ingredients in the medication itself, or those who are on beta blockers, which can interact poorly with oral immunotherapy.

What Otolaryngologists Need to Know

Physicians who treat patients with grass or ragweed allergies should know that there’s an alternative to allergy shots, said Linda Cox, MD, the immediate past president of the American Academy of Allergy, Asthma and Immunology. “As far as we know, serious side effects are rare, and from a positive standpoint, patients have a new way to treat seasonal allergy.”

The cost to patients for allergy treatments varies with the number of allergies being treated as well as the frequency with which the shots are given, but Dr. Sautter said that a good estimate for one month of allergy shots is approximately $75. Citing a Merck press release, Dr. Sautter added that the cost of one Grastek or Ragwitek pill is $8, or $240 for a one-month supply.