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Biotech / Medical : Merck -- Ignore unavailable to you. Want to Upgrade?


To: muddphudd who wrote (1178)4/20/1999 2:55:00 PM
From: Dan Spillane  Respond to of 1580
 
So far, the FDA appears to have a policy that they won't change the label until a COX-2 drug has been out for some time. This makes sense...I would think Celebrex would be the first to qualify for a better label.

(you said)
Did the panel decide whether Vioxx will get a more favorable labelling than Celebrex with regard to NSAID GI effects??? That's the big question.



To: muddphudd who wrote (1178)4/20/1999 3:27:00 PM
From: William Partmann  Read Replies (1) | Respond to of 1580
 
Not a complete answer but fills in some of the questions.

U.S. FDA panel backs Merck's Vioxx for acute pain
GAITHERSBURG, Md., April 20 (Reuters) - A Food and Drug Administration panel on Tuesday voted to back Merck's (MRK - news) pain killer Vioxx to treat acute pain.

The panel voted 6-0 with two abstentions to recommend approval for Vioxx for acute pain, such as menstrual pain and post-surgical pain. Earlier, the panel had supported Vioxx for treating pain associated with osteoarthritis, the wear-and-tear joint pain that afflicts 21 million Americans.

The nation's largest drug maker hopes Vioxx will be a competitor to Monsanto Co.'s (MTC - news) popular arthritis drug Celebrex, which rocked the market this year by becoming one of the best-selling new drugs in history.

Both Vioxx and Celebrex are so-called COX-2 inhibitors, which have shown the ability to kill pain without the sometimes serious side effects of older drugs.

They work by inhibiting the COX-2 enzyme while causing far fewer ulcers and gastrointestinal problems than commonly used drugs. Those side effects send about 100,000 Americans to the hospital each year, and between 10,000 and 20,000 die.

Drug industry analysts had said they expected the FDA panel to support Vioxx but said its success would depend on what the agency puts on the drug's label regarding uses and side effects.