(Adds company details, byline, updates shares)
By Susan Heavey
WASHINGTON, April 16 Earlier use of
Bristol-Myers Squibb Co.'s (BMY.N) Avalide to treat some
hypertension patients should win U.S. approval, a Food and Drug
Administration reviewer said in documents released on Monday.
The drug, co-marketed by Sanofi-Aventis (SASY.PA) (SNY.N),
was first approved in 1997 and is already cleared to treat
hypertension after use of either irbesartan or
hydrochlorothiazide fails to help reach desired blood pressure
Bristol is seeking FDA approval to do away with that
requirement and market Avalide -- which combines irbesartan and
hydrochlorothiazide -- as a first option for patients with
severe hypertension who are unlikely to lower their blood
pressure with just one drug.
The drugmaker submitted two new studies to the agency, one
investigating Avalide as the first treatment for severe
hypertension and another looking at use of the drug in moderate
On Wednesday, an FDA panel of outside advisers is scheduled
to discuss the data and whether to recommend that the agency
approve the new use. The agency is not bound by their decision
but usually follows their advice.
The FDA reviewer said data showed the combination drug "was
significantly more effective." No new safety problems were
found in either study, the staffer added, although more side
effects were seen with the highest doses.
Post-approval actions, which could include more studies or
patient registries, are not needed, the reviewer also said in
the documents posted on the FDA Web site here
Avalide is a type of angiotensin II receptor blocker that
aims to treat hypertension, or high blood pressure -- a
condition that can increase the risk of heart attack, stroke
and other complications.
Side effects include dizziness, headaches and abnormally
low blood pressure, among other problems, according to the FDA
Bristol and Sanofi also market irbesartan alone under the
Deciding how to treat individual patients can be difficult,
Bristol said in separate documents also released on Monday. But
using Avalide early could help prevent emergency situations and
heart complications, the company wrote.
In addition to the two studies, the company also said "data
collected during 10 years of post-marketing surveillance
provide a reassuring long-term safety profile."
Shares of Bristol were up 19 cents, or less than one
percent, at $28.51 in midday trade on the New York Stock