US FDA panel backs Pfizer antifungal drug

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Thursday October 4, 4:28 pm Eastern Time

US FDA panel backs Pfizer antifungal drug

By Richwine

SILVER SPRING, Md., Oct 4 (Reuters) - A U.S. advisory panel on Thursday

backed Pfizer Inc.'s (NYSE:PFE - news) antifungal drug Vfend for treating a

type of infection that can be fatal for people with weak immune systems.

The panel unanimously urged the Food and Drug Administration (FDA) to

approve Vfend to fight aspergillosis, a fungal infection caused by a common

mold. Aspergillosis, while rare, is hard to treat and often deadly.

The vote moved Vfend a step closer to the U.S. market because the FDA

usually follows its panels' advice.

Aspergillosis is most dangerous for cancer or AIDS patients or people who

have had bone marrow or organ transplants. Even with treatment, more than

half of patients with invasive aspergillosis die, and deadly cases are on

the rise, Pfizer said.

In one of Pfizer's studies, about 70 percent of aspergillosis patients

treated with Vfend survived 12 weeks, compared with about 58 percent given

standard antifungal therapies.

``We saw superior efficacy and a survival benefit,'' Dr. Helen Boucher,

Pfizer's senior associate director for clinical development, told the panel.

Because the infection is so dangerous, Vfend's potential benefits outweighed

risks of visual disturbances, liver injury and skin rashes, Pfizer said.

Vision problems and liver abnormalities disappeared after the drug was

stopped, the company said.

Panel members agreed with Pfizer's analysis. ``I think the data are pretty

strong, and it's pretty straightforward,'' said Dr. Wood, a senior

clinical investigator at the National Cancer Institute.

The panel, by an 8-2 vote, declined to support approving Vfend for giving to

patients with persistent fevers and low white blood cell counts who are at

risk for serious fungal infections. Pfizer also wants permission to market

Vfend for other types of yeast and mold infections, but the FDA did not ask

the panel's opinion on those conditions.

Vfend comes in intravenous and oral forms, enabling patients to receive

initial treatment through an IV in the hospital and complete the therapy at

home with pills.

Some industry analysts said that would give Vfend an advantage over rivals

such as Merck and Co.'s (NYSE:MRK - news) Cancidas, approved earlier this

year.

Banc of America Securities analyst Leonard Yaffe said he expected Vfend,

which he called one of the top three drugs in Pfizer's pipeline, to win FDA

approval later this year and generate worldwide sales of $325 million next

year.

Pfizer shares closed at down a half percent, or 23 cents, at $41.02 on the

New York Stock Exchange.