UPDATE 1-EU agency recommends against Takeda's Ramelteon

Mon Jun 2, 2008 7:33am EDT
 
[-] Text [+]

(Adds background on drug)

LONDON, June 2 (Reuters) - The European Medicines Agency has recommended against approval of Takeda Pharmaceutical Co Ltd's (4502.T) insomnia drug Ramelteon for adults, the London-based watchdog said on Monday.

The decision is a fresh setback for a drug that analysts have widely viewed as a commercial failure. It was approved for sale as Rozerem in the United States in 2005.

The treatment has a smaller risk of abuse and dependency than other sleep drugs but is less effective. It generated $88 million in sales in the some $4 billion-a-year U.S. insomnia drug market in the nine-month period to December.

Last year Takeda applied for the right to sell the drug in Europe, hoping to enter a market led by Sanofi-Aventis's (SASY.PA) Ambien. In February, it also sought marketing approval for the treatment in Japan. (Reporting by Michael Kahn; Editing by David Holmes)

 
Join the Reuters Consumer Insight Panel and help us get to know you better

Join the Reuters Consumer Insight Panel and help us get to know you better