WASHINGTON (Sep. 24)
An advisory panel of the U.S. Food and Drug Administration has recommended that the FDA approve a new Israeli drug to help treat multiple sclerosis.
Initial research for the drug was carried out by researchers Michael Sela, Ruth Arnon and Dvora Teitelbaum of the Weizmann Institute of Science in Rehovot, Israel.
Clinical trials carried out in recent years show that the drug, called Copaxone, reduces the number of attacks in patients with a relapsing-remitting form of M.S., according to the Weizmann Institute.
It also ameliorates the condition of people in the early stages of the disease and produces almost no negative side effects.
Copaxone would be the third drug available in the United States to treat the disease.
If approved, Copaxone would be marketed in the United States by Teva Marion Partners, in Kansas City, Mo., a partnership created by Israel’s Teva Pharmaceutical Industries Ltd. and an American company, Hoechst Marion Roussel Inc.
About 250,000 to 350,000 people in the United States suffer from M.S. The disease, which causes deterioration of movement, speech and basic bodily functions, is more common among women, and generally strikes between the ages of 20 and 40.
The FDA is expected to grant approval for marketing of the drug within the next few weeks.
“We join all people with MS in urging the FDA to act swiftly in their final deliberations,” the National Multiple Sclerosis Society said in a statement.