FDA approvals, actions involving allergies

In recent months, the FDA has approved three sublingual oral immunotherapy tablets for treating grass and ragweed allergies, as well as omalizumab for chronic idiopathic urticaria.

An FDA advisory panel advised against a proposal to allow montelukast sodium as an over-the-counter treatment for patients with allergic rhinitis and other respiratory allergies. Here are highlights from Healio Allergy/Immunology:

FDA approves Oralair, first SLIT agent for grass allergies

The FDA approved the first sublingual oral immunotherapy (SLIT) tablet for grass allergies in the United States in April.

Karen Midthun

“While there is no cure for grass pollen allergies, they can be managed through treatment and by avoiding exposure to the pollen,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The approval of Oralair (Greer/Stallergenes) provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.” With perspective.Read more

Grastek, second SLIT agent for grass allergies, approved

The FDA approved the second sublingual immunotherapy agent within 2 weeks of the Oralair approval. Grastek (Timothy Grass Pollen Allergen Extract, Merck) sublingual immunotherapy tablets are indicated for the treatment of grass pollen-induced allergic rhinitis, with or without conjunctivitis, in patients aged 5 to 65 years.

David I. Bernstein

“With the FDA approval of Grastek, allergy specialists now have a new sublingual approach to offer these patients for their grass allergies,” David I. Bernstein, MD, professor of medicine and environmental health, division of immunology, allergy and rheumatology, University of Cincinnati College of Medicine, said in a press release. With perspectives. Read more

Ragwitek, first SLIT agent for ragweed allergies, approved

In April, the FDA also approved Ragwitek (Ambrosia artemisiifolia extract, Merck) sublingual immunotherapy (SLIT) tablets indicated for the treatment of short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis, in adults aged 18 to 65 years.

“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” Karen Midthun,MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. With perspectives.Read more

FDA approves Xolair for chronic idiopathic urticaria

The FDA approved omalizumab for the treatment of chronic idiopathic urticaria, a form of chronic hives, in March. It is the first medication approved for the condition since H1-antihistamines.

Omalizumab (Xolair, Genentech/Novartis) was initially approved in the United States in 2003 for patients aged 12 years and older with moderate-to-severe persistent allergic asthma due to year-round allergens not otherwise controlled by inhaled corticosteroids. With perspective. Read more

FDA advisory panel advises against Singulair OTC

In May, the FDA’s Nonprescription Drugs Advisory Committee voted 11-4 against a proposal to move montelukast sodium (Singulair, Merck) over-the-counter for patients with allergic rhinitis and other respiratory allergies.

The proposed OTC use indicated Singulair “temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose,” according to Andrea Fisher, FDA public affairs specialist. With perspectives.Read more