Jan 22 Arena Pharmaceuticals Inc said
the European health regulator had raised concerns with the
company's obesity drug, Belviq, sending its shares down as much
as 10 percent.
The European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) raised objections related to
issues such as tumors in rats, heart valve disorders and
psychiatric events, Arena said in a regulatory filing on
"The CHMP requests that we further justify Belviq's overall
benefit-risk balance taking these issues into consideration,"
the San Diego, California-based company said.
Arena said it expects the regulator to make a final decision
on Belviq in the first half of 2013. Belviq is designed to block
appetite signals in the brain to help people feel full after
eating smaller amounts of food.
The U.S. Food and Drug Administration had raised similar
concerns over Belviq before eventually approving the drug in
Arena had at that time argued that the incidence of tumors
was specific to rodents and humans have different biological
The FDA's main concern though was Belviq's impact on heart
valves, which could signal broader cardiac damage.
Post approval, the FDA directed Arena to conduct six
follow-up studies, including a long-term study of whether Belviq
increases the risk of heart attack or stroke.
Arena's shares fell 8 percent to $8.98 in mid-day trade on
(Reporting By Pallavi Ail in Bangalore; Editing by Supriya