See this excerpt from a Bloomberg update (reson for lack of euphoria so far):
One of the major issues at the meeting will be whether
Searle can convince the panel that its drug doesn't need the
standard warning label about gastrointestinal side effects
carried by many existing painkillers. FDA reviewers said
they can't yet be sure of the long-term effects of the new drug
and warned that new, unforeseen side effects could appear.
Several speakers at an open public hearing raised similar
concerns. Sidney Wolfe, head of Public Citizen's Health Research
Group, said there isn't yet enough evidence to allow Celebrex,
also known as celecoxib, on the market without the standard
warning label.
''Purported new classes of drugs such as celecoxib offer not
only new mechanisms of action, but also new mechanisms of
potential toxicity and the possibility of a new spectrum of
adverse events,'' Wolfe said in a statement to the panel.
If the panel turns down Searle's request to avoid the
standard warning label it would be a blow to the company's plans
to distinguish Celebrex from existing treatments. The panel will
discuss this issue this afternoon.
Expectations for the class of drugs, known as Cox-2
inhibitors, are high. Analysts say Merck and Searle's drugs could
generate combined annual sales of as much as $5 billion. Still,
the companies may face a challenge convincing health insurers
that it's worth paying more for painkillers even if they can
claim the drugs are safer.
The drugs are likely to be sold at much higher prices than
existing painkillers such as Roche Holding AG's Naprosyn and
Novartis AG's Voltaren.
If approved, Celebrex would also compete against Immunex
Corp's Enbrel and Hoechst AG's Arava, both recently approved for
the treatment of rheumatoid arthritis. |
