FDA committee supports approval of two new sublingual allergy tablets

tabletsLast week, the FDA Allergenic Products Advisory Committee unanimously supported approval for two new sublingual allergy tablets (Oralair and Grastek).  Allergy tablets are an alternative to conventional allergy shots. Both tablets are indicated for the treatment of grass pollen allergy. Oralair is made by a French pharmaceutical company Stallergenes and contains 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Grastek (aka Grazax in Europe) is made by ALK-Abello and Merck and contains only Timothy Grass.  Although both tablets are available in Europe, FDA approval may not occur for a year or more.

For more than a century, physicians have been using the process of desensitization to treat environmental allergies. Introducing small amounts of allergen (i.e. dust mites, pollens) over and over again, helps to re-educate the immune system. Using current dosing regimens, the results are impressive. Large analyses show a decrease in allergy and asthma symptoms of ~ 75%. Other benefits include a decreased need for medications (60%) and decreased risk of developing new allergies or asthma. Unfortunately, these results require commitment and frequent office visits.

Which is better, allergy tablets or shots? 

1. Effectiveness. There have been few good studies comparing allergy tablets (or drops) with shots. Looking at placebo controlled trials (comparing treatment with a ‘fake’ injection or tablet), allergy shots appear to provide higher levels of relief.

Winner: shots.

2. Convenience. Each and every allergy shot must be given in the allergist’s office.  Although the first dose is given at the allergist’s office, allergy tablets are continued at home.

Winner: tablets.

3. Flexibility.  Those tablets currently available (in Europe) contain only single allergens, such as for grass. Other tablets in development include ragweed or dust mites. Allergy shots are customized by allergists to contain multiple allergens, such as for trees, grasses, weeds, dust mites, animal danders and/or molds.

Winner: shots.

4. Compliance. Without completing a recommended course of allergy tablets or shots, patients will not get their optimal result. Unfortunately, neither treatment route has demonstrated a high completion rate. A recent study from the Netherlands  found that only 7% of those getting allergy tablets (or drops) completed the recommended three years of treatment. Surprisingly, that was even worse than the 23% of patients getting allergy shots. One possible reason, allergy shots may be spread out to once monthly versus daily use of allergy tablets.

Winner: neither.

5. Cost. Producing a high quality allergy tablet (or drop) requires significantly higher amounts of material than allergy shots. However, there are less associated costs, i.e. office visits and injections. Unfortunately, an accurate comparison is not possible at this time, until allergy tablets are approved by the FDA, there is no insurance coverage.

Winner: unknown.

6. Safety. Both tablets and shots are well tolerated. Both have the potential to cause local reactions, either an itchy mouth or an itchy harm. Both have the potential to cause systemic (more severe) reactions. Although the risk is low, it is definitely higher with shots (compared to tablets).

Winners: tablets.

6. Conclusion. The best allergy treatment is one that works quickly and lasts forever. Allergy tablets, drops and shots will continue to get better. For example, four doses of an investigational cat vaccine, given over 12 weeks, had a significant improvement in symptoms two years later. Stay tuned.

 

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