Biodoc-- Would you, Bradpalm, or someone else familiar with the FDA regs, let us know if it is expectable that they would reject a new drug that is only equivalent and not superior to an existing drug? I'm asking since they might feel that Vasomax is not superior to Viagra, and then would reject on that basis. I'm attaching below a copy of a rejection that was received today, on that basis. I note that the company that developed the rejected drug felt their drug did have an edge, but the FDA did not agree.
FDA panel rejects Hirulog drug for angioplasty
Reuters, Friday, October 23, 1998 at 16:23
BETHESDA, Md., Oct 23 (Reuters) - A new drug that keeps
blood from clotting during angioplasty was judged not ready for
U.S. Food and Drug Administration (FDA) approval by a panel of
federal advisers on Friday.
Hirulog, derived from leech saliva, will be sold by The
Medicines Company, a privately held concern based in Cambridge,
Mass. It specifically blocks the production of thrombin, a key
component of clots.
The Medicines Company licensed rights to Hirulog from
Biogen Inc. (NASDAQ:BGEN) in 1997. Biogen abandoned Hirulog
development in 1994 saying it was no longer a strategic fit,
and will receive a sales-based royalty upon approval.
The FDA committee said bivalirudin, the generic term for
Hirulog, was equivalent but not superior to the blood thinner
heparin in preventing angioplasty complications.
"I believe that it's equivalent or better, but belief
doesn't quite get you there," said panelist Marvin Konstam of
the New England Medical Center.
Most advisers said they doubted The Medicine Company's
claim that Hirulog was safer because it caused less major
bleeding. The heparin dose used in the company's studies,
completed in 1995, was much higher than that used today,
panelists said.
"This regimen of heparin was relatively aggressive," said
panelist Dan Roden of Vanderbilt University, adding that it may
have caused more bleeding in patients taking heparin.
The Medicines Company claimed Hirulog cut major bleeding by
at least 60 percent.
But panelist John DiMarco of the University of Virginia
Hospital said: "I can't be certain (Hirulog) would be superior
in a trial today using a different protocol."
The FDA usually follows its panels' advice.
Hirulog is given intravenously during angioplasty to help
prevent death or heart attacks from clots that might break off.
The aim is to use Hirulog instead of heparin, which can
cause heart attack or death in up to 10 percent of patients,
said Clive Meanwell, president of the Hirulog development
program at The Medicines Company. Heparin can also cause
dangerous hemorrhaging.
In the company's two main studies, each of which had 2,000
patients, Hirulog reduced death, heart attacks, or other
significant complications in the first week by about 11-17
percent -- not as much as the hoped for 33 percent.
And the results were not significantly better than those
seen with heparin.
If approved, Hirulog would likely be used in combination
with drugs like Eli Lilly's Reopro and Cor Therapeutics'
Integrilin, which block platelets from clumping.
Eric Topol, a cardiologist from the Cleveland Clinic
Foundation and consultant to The Medicines Company, said
Hirulog's safety made it an attractive alternative to heparin.
"The chance of hemorrhage risk is higher than ever before,"
said Topol, noting that many angioplasty patients get multiple
blood-thinning drugs, including the anti-platelet therapies.
"Anything we can have that reduces that risk is welcome."
898-8383, E-Mail washington.equities.newsroom@reuters.com))
Copyright 1998, Reuters News Service
Companies or Securities discussed in this article:
Symbol
Name
NASDAQ:BGEN
Biogen Inc |
