U.S. FDA panel: data support safety, efficacy of Merck allergy drug
(Reuters) - Merck & Co's experimental drug Ragwitek, a treatment for ragweed allergies, appears safe and effective for use in patients between the ages of 18 and 65, a panel of advisors to the U.S. Food and Drug Administration concluded on Tuesday.
The panel voted 6 to 2, with one abstention, that data supported the drug's efficacy. It voted 8 to 0, with one abstention, that the data supported the drug's safety.
About 30 million people in the United States suffer allergies to ragweed pollen, according to the FDA.
Analysts see eventual Ragwitek sales of about $300 million. However, Morningstar analyst Damien Conover believes sales could reach as much as $1 billion if enough allergy sufferers prefer Ragwitek, a 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.