Jan 24 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
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.