The U.S. Food and Drug Administration (FDA) this week approved another sublingual grass immunotherapy tablet (Grastek) as well as a sublingual ragweed immunotherapy tablet (Ragwitek). The approval of Grastek comes a few weeks after the first sublingual grass tablet, Oralair, was approved for the treatment of grass pollen induced allergic rhinitis and conjunctivitis. Oralair is a mixture of five major Northern Pasture grass pollens (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass), while Grastek contains a single grass pollen (Timothy Grass). Given the high rate of cross-reactivity among the Northern Pasture grasses, either version would be expected to be effective as immunotherapy -- especially since Timothy Grass is the most important of this group.
While I'm still not impressed, as I mentioned in my initial blog on Oralair, as I highly doubt that any of these products will get much use in the United States, it is interesting to see how quickly these products were approved following Oralair. I do think the stage is set for quick FDA approval of a cat and dust mite sublingual tablets -- then I'll be more impressed because these products will reach a larger group of allergy sufferers. After those tablets, however, it will be difficult for any additional allergens (such as tree pollen, other weed pollens and dog dander) to be approved since other allergen extracts (except for venoms) are not standardized on a major allergen.
Urticaria, also known as hives, can affect up to 20 percent of the population. Most people with chronic urticaria (hives lasting more than 6 weeks) have the suspicion of some type of food allergy as the cause of their hives. In many instances, people are concerned that food additives or preservatives are the cause of their symptoms. These people may attempt to follow a preservative-free diet, with possible improvement in their symptoms. When they see an allergist for further evaluation, they find that there is no simple way to test for allergy to additives and preservatives. A recent study sought to determine if eleven different food preservatives and drug additives were responsible for chronic hives in 100 different people. Find out the results of this interesting study.
Food allergies and contact aeroallergens (such as pet dander and dust mites), are common triggers for atopic dermatitis. Irritants and dry weather can also worsen symptoms. People with atopic dermatitis may also have a flare in their symptoms due to an infection caused by bacteria, fungi or viruses. It can be difficult to predict when a flare of atopic dermatitis may occur, but once itching has become severe and scratching occurs, it can be difficult to get symptoms under control. There is a need for a biomarker for atopic dermatitis that can be followed to predict exacerbations of atopic dermatitis. Urinary biopyrrin may represent a biomarker for atopic dermatitis that could help predict exacerbations before they occur, so that appropriate treatments can be started in order to prevent severe attacks.
This week, the U.S. Food and Drug Administration (FDA) approved a sublingual immunotherapy tablet for the treatment of grass allergy. Oralair, the brand name for the tablet, is the first sublingual immunotherapy (SLIT) treatment approved by the FDA for the treatment of allergic rhinitis and allergic conjunctivitis caused by grass pollen. Immunotherapy, in the form of allergy shots, has been used in the U.S. for more than one hundred years. Some allergists in the U.S. have offered SLIT (allergy drops placed under the tongue) as an experimental (non-FDA approved) therapy for years, although SLIT has been used around the world for many decades -- meaning this is not a new therapy.
Oralair has been shown in multiple studies to be a safe and effective treatment for the symptoms of grass allergy, and unlike allergy shots, is safe enough to be taken at home. The treatment needs to be started months before grass season, however, and can either be continued throughout the year or stopped after grass season has ended. It is approved for people 10-65 years of age.
In my opinion, Oralair has little chance of success in the U.S. First, I will be surprised if many physicians prescribe this product. Allergists who treat allergic rhinitis would rather prescribe allergy shots (which are probably more effective), or allergy drops mixed in their own office. These allergy drops aren't limited to grass allergy, but can also be used for other pollens, pet danders, dust mite and in some cases, mold allergy. Any physician prescribing Oralair will also be incurring a risk/liability for allergic reactions caused by the medication, which while rare, can still occur. The first dose of Oralair is recommended to be given in a physician's office with monitoring for 30 minutes, which most non-allergists aren't comfortable doing. Thereafter, the product can be taken at home. Injectable epinephrine should always be available for a person taking SLIT, including Oralair. Lastly, most non-allergists are ill-equipped to appropriately diagnose and treat allergic rhinitis, and are unlikely to be able to explain to patients how immunotherapy works, the risks and benefits, as well as the fact that Oralair doesn't treat immediate symptoms -- months are required to realize benefits. Most people are looking for relief with they have symptoms, not 4 months before their symptoms start. Therefore, while the approval of Oralair represents an exciting step in the field of allergy, since SLIT is now an FDA approved treatment for allergies, I doubt that Oralair will get much use in this country.