FDA Approves Ragwitek... Ragweed Allergy Tablet by Mouth (Instead of Allergy Shots)

The FDA formally approved Ragwitek, the third new sublingual allergy tablet to be sold in the United States this year that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Ragwitek is the first sublingual allergy tablet to treat ragweed. Although Oralair and Grastek are two other sublingual tablets that have already been approved by the FDA, they treat grass allergies rather than ragweed.

Ragwitek is a tablet made by Merck and treats patients aged 18-65 years who are allergic to only short ragweed. Ragwitek has a simple regimen of 1 sublingual tablet daily starting 12 weeks before the ragweed season and continued until the end of the ragweed pollen season. As with Oralair and Grastek, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

Although in next few weeks US physicians should be able to start prescribing Ragwitek, treatment needs to actually begin in early summer thru the fall for full effectiveness.

As with Oralair and Grastek, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

The wholesale price of both Grastek and Ragwitek will be $8.25 per pill, or $247.50 for a 30-day supply. The wholesale price of Oralair will be $10 per pill, or $300 for a 30-day supply.

Sources:
FDA approves Ragwitek for short ragweed pollen allergies. FDA 4/17/14

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New Ragweed Under the Tongue Pill Instead of Allergy Shots Recommended by FDA Panel

Yesterday, the FDA Allergenic Products Advisory Committee supported approval for a new sublingual allergy tablets (Ragwitek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Given this is only a panel recommendation, final "official" FDA approval may not occur for another year or so for sale/distribution under prescription in the United States.

Ragwitek is made by ALK-Abello and Merck and treats patients aged 18-65 years who are allergic to only short ragweed pollen. The way Ragwitek is taken is placement of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the ragweed pollen season. The first dose is given in a medical office to ensure safety with all other doses taken at home. The tablet dissolves in less than 10 seconds.

Epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Ragwitek is similar to Oralair and Grastek which treat only grass allergy. Oralair and Grastek were both recommended by the FDA panel last year.

Source:
Sublingual Ragwitek Backed FDA Panel for Ragweed Allergy. Medscape 1/28/14

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Pill Rather than Allergy Shots for Ragweed

If all goes well, in 2013 there will be a pill a patient can take rather than allergy shots to tone down the immune response to not only grasses (Grazax), but also ragweed.

The active ingredient in this ragweed pill is Ambrosia artemisifolia, the chemical found within ragweed that causes allergy symptoms.

Phase III trials with this pill taken once/day for 52 weeks conducted by Merck show a significant improvement in allergy symptoms by nearly 25%. Use of allergy medications like anti-histamines and steroid nasal sprays decreased by about 40%.

Just as in allergy shots, it is felt that repeated exposure to the actual allergen will induce immune tolerance. As such, rather than treating the symptoms as with anti-histamines, this medication will theoretically prevent the allergy from appearing in the first place.

Of course, side effects were present and akin to allergies it is supposed to prevent.

There is no published data yet, but results were presented at the 2012 AAAAI meeting.

Source:
New allergy pill may tame ragweed symptoms. MSNBC 3/4/12

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