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FDA to review Merck & Co's allergy immunotherapy

Accepts application for oral tablet to protect against ragweed-based allergies

Merck & Co said that the US FDA is to review its application for an investigational immunotherapy tablet to protect against ragweed-based allergies – a form of hay fever caused by the release of pollen from weeds.

It follows a similar announcement for Merck's immunotherapy for grass pollen allergies, which was accepted for review by the US regulator in March 2013.

US-based pharma company Merck says it expects the FDA's review for both allergy treatments to be completed in the first half of 2014.

Both the ragweed and grass pollen immunotherapies are developed in partnership with Denmark-based firm ALK-Abello and Merck has rights to develop, market and distribute approved products in the US, Canada and Mexico.

The deal includes an additional immunotherapy tablet in development for the treatment of allergies to house dust mites, although this has yet to be accepted for review by the FDA.

The Biologics License Application (BLA) for the ragweed allergy immunotherapy is supported by five studies involving adults over the age of 18 with ragweed induced allergic rhinitis.

The tablet is designed to be taken under the tongue and helps treat the underlying cause of allergic rhinitis – allergic inflammation of the nasal airways – by generating an immune response to help protect against the targeted allergen.

According to the Asthma and Allergy Foundation of America, about 10 to 20 per cent of Americans face hay fever problems during the summer, of which 75 per cent are due to an allergy to ragweed pollen.

In the US, there are 17 different species of ragweed, and they are most commonly in rural areas of the Midwest and Eastern states.

One plant can produce up to one billion pollen grains, which can travel as far as 400 miles away from the original source.


9th May 2013

From: Sales



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