No serious side effects with Merck allergy pill: FDA documents

[January 25, 2014]  By Bill Berkrot

(Reuters) — No serious safety concerns were raised over Merck & Co's experimental pill for ragweed allergies, according to FDA documents Friday, ahead of a meeting next week of outside medical experts who will discuss whether the drug merits approval.

The Allergenic Products Advisory Committee will meet on Tuesday to review Ragwitek, a pill placed under the tongue that, if approved, would be an alternative to regular injections administered by doctors for ragweed pollen allergies.

At the meeting, the panel will be asked to discuss whether available clinical trial data supports the safety and the efficacy of the product in persons 18 years of age and older and make recommendations to the U.S. Food and Drug Administration.

The committee will also be asked to recommend to the agency whether any additional studies of the drug might be needed.

The FDA documents appeared to favor the drug's safety, saying "none of the adverse events categorized as serious by investigators or (Merck) are considered related to the study drug."

The document also said "there were no deaths in any of the five clinical development trials of Ragwitek."

About 30 million people in the United States suffer allergies to ragweed pollen, the FDA said.

Analysts see eventual Ragwitek sales of about $300 million. However, Morningstar analyst Damien Conover said sales could reach as much as $1 billion if enough allergy sufferers prefer the pill to injections.

The pill, which is comprised of extracts from short ragweed pollen, would be taken daily beginning 12 weeks prior to the start of the ragweed pollen season and throughout the season.

Merck filed its application seeking U.S. approval of Ragwitek last March. The drug, and another pill for grass pollen allergies called Grastek, are being developed along with Danish Drugmaker ALK Abello.

In December, an FDA advisory committee unanimously recommended approval of Grastek.

Merck shares were down 9 cents at $51.51 on the New York Stock Exchange, against the broader markets, which were down more than 1 percent.

(Reporting by Bill Berkrot; editing by Bernadette Baum)

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