With a U.S. FDA advisory panel hearing on diet drug rimonabant (Acomplia / Zimulti) fast approaching, analysts are beginning to speculate that a recent rash of drug scares may weigh against early approval of sale of the diet pill in the United States.
Bear Stearns analysts said the new concerns raised in the past 10 days over the safety of diabetes drug Avandia may well increase the likelihood that the FDA -- in considering whether to approve Acomplia -- will choose to err on the side of caution and seek additional data.
The Avandia scare, together with recent publicity about safety issues involving top-selling anemia drugs Aranesp, Epogen and Procrit, have refocused attention on drug safety, rekindling memories of the stunning 2004 withdrawal of painkiller Vioxx from the market.
As it happens, the FDA's Endocrinologic and Metabolic Drugs advisory panel -- which will discuss side-effects associated with Acomplia at a day-long meeting on June 13th -- is the same group of advisors that consider issues involving diabetes drugs like Avandia.
"In view of the increasing number of scares in the industry ... we believe the FDA endocrinology division may not be keen to make a potentially controversial decision quickly, with several issues regarding potential side effects still outstanding," the Bear Stearns analysts said.
Rimonabant is the first in a new class of drugs that operates by blocking CB-1 receptors in the brain. Both in clinical trials and in more widespread use since the drug went on sale in Europe last summer, Acomplia has been linked to depression and other psychotic side effects.
A number of those who have been critical of how the FDA oversees patient safety are expected to mount a major effort to see that these side-effects are thoroughly explored at the June 13th meeting.
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