FDA Approves Grastek, Merck's Grass Allergy Pill; Joins Oralair In New Round Of Immunotherapies
Spring is here, and it’s bringing seasonal allergies along with it. So it’s no surprise that a new round of allergy medications are getting approved by the Food and Drug Administration (FDA) — though they probably should have looked to an earlier release — the most recent of which is Merck’s Grastek, a sublingual — going under the tongue — pill for treating grass allergies.
Grastek is the second sublingual oral immunotherapy (SLIT) to be approved this month and the first of three that Merck plans to market, MedPage Today reported. Once placed under the tongue, it dissolves and super small doses of timothy grass extract are released into the body with the purpose of weaning a person’s allergies out of severity. Although it’s only made with the extract of timothy grass pollen, it’s cross reactive, and therefore can help treat other grass allergies as well, including sweet vernal, orchard, perennial rye, Kentucky blue, and red top.
Late-stage trials showed that the drug was able to reduce allergy symptoms in patients by almost 20 percent, compared to a placebo, according to Fierce Biotech. It’s been approved for use among those who suffer from grass pollen-induced allergic rhinitis with or without conjunctivitis in adults up to 65 and children as young as 5. Merck may have been a little late, considering that allergy season has already started, because a person who plans on going on Grastek must begin treatment at least 12 weeks before the season begins — Merck plans to start marketing the tablets with partner ALK-abello at the end of the month.
Still, the tablets could be a good alternative to current injection treatments, which have been trusted for years. “Every grass pollen season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication,” said Dr. David Bernstein, professor of medicine and environmental health in the Division of Immunology, Allergy and Rheumatology at the University of Cincinnati College of Medicine, in a Merck press release. “These patients often have multiple sensitivities. Some of these patients may be candidates for immunotherapy, but decline allergy shots. With the FDA approval of Grastek, allergy specialists now have a new sublingual approach to offer these patients for their grass allergies.”
But Grastek is the second SLIT to be approved. Earlier this month, French pharmaceutical company Stallergenes got Oralair approved for use among five of the same grasses that Grastek treats, Medscape reported. Late-stage trials showed that it was 16 to 30 percent effective in reducing allergy symptoms. Although they are sure to become competitors, Oralair was only approved for children as young as 10.
Both medications would be prescribed with a required auto-injectable epinephrine prescription, as it’s possible for patients to experience adverse effects. Reported side effects for both include itchy mouths and throat irritation.