FDA Advisory Committee Supports Two New Sublingual Grass Tablets

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The FDA advisory committee has recommended approval of two new sublingual tablets for the treatment of grass allergy.  The FDA is not bound to follow the recommendation of the advisory committee, but it usually does. So, what does this mean for you, dear reader?

First off, the word sublingual means “under the tongue”. These new treatments are a form of sublingual immunotherapy, or SLIT. I’ve blogged about the pros and cons of SLIT before and they still hold true today. In short, subcutaneous immunotherapy, aka SCIT, aka allergy shots, is probably more effective, works quicker, lasts longer and is better at preventing new allergies and complications. SLIT is more convenient and safer. Compliance is pretty poor for both.

The big drawback for the new grass SLIT tablets is their lack of flexibility and their narrow focus. One tablet contains only Timothy grass – a representative pasture grass – and the other contains a mixture of pasture grasses. This is great if all you have is pasture grass allergy; but if you have hot-weather grass allergy, like Bermuda and Bahia, or if you’re allergic to any of the other myriad allergens, like trees, weeds, dust mites, cats, dogs, cockroaches or molds, then you’re out of luck. In my practice, I would estimate that less than 1% of my allergic rhinitis patients are sensitive to only pasture grass. Allergy is regional, so this might be different elsewhere.

Perhaps more important than the individual tablet approvals is the fact that the FDA might approve SLIT at all. Up until now, SLIT has been a strictly off-label practice in the U.S. and, because it lacks FDA approval, it has not been covered by insurance. This certainly won’t lead to wholesale SLIT approval across the board, but it does get a foot in the door. For SLIT to be a meaningful treatment for most allergy sufferers it will have to be individualized and the approval process for that will be more complicated.

Stay Tuned.

Dr. O

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