FDA Says There's No Serious Side Effects With Merck Allergy Pill
ByFDA document released Friday show that there are no serious safety concerns regarding Merck & Co's experimental pill for ragweed allergies, Reuters reported.
The Allergenic Products Advisory Committee will meet on Tuesday to review the merits of Ragwitek, "a pill placed under the tongue that, if approved, would be an alternative to regular injections administered by doctors for ragweed pollen allergies," Reuters reported.
During the meeting, the panel will have to discuss whether available clinical trial data supports the safety and the efficacy of the pill in persons 18 years of age and older and make recommendations to federal health regulators. They will also be asked to recommend to the agency whether any additional studies of the drug might be needed.
FDA officials seem to be in favor of the drug, Reuters reported.
According to documents Reuters obtained, FDA officials have said "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."
According to Reuters, analysts predict Ragwitek will make sales worth $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 experimental pill is comprised of extracts from short ragweed pollen and if approved, would be taken daily beginning 12 weeks prior to the start of the ragweed pollen season and throughout the season.
The application seeking U.S. approval of Ragwitek was filed by Merck last March. Ragwitek, and another pill for grass pollen allergies called Grastek, are being developed along with Danish Drugmaker ALK Abello, Reuters reported.
In December, an FDA advisory committee unanimously recommended approval of Grastek.