GILD mentioned on CNBC this morning:
Gilead: FDA Says Data Insufficient For Forvade Mktg OK
Dow Jones News Service ~ May 6, 1997 ~ 9:42 pm EST
(MORE) DOW JONES NEWS 05-06-97
9:42 PM
Gilead/FDA -2: Gilead To Cooperate With FDA >GILD
FOSTER CITY, Calif. (Dow Jones)--Gilead Sciences Inc. (GILD) Tuesday said
the U.S. Food and Drug Administration declined to give marketing clearance to the
company's Forvade brand of cidofovir gel for the treatment of refractory herpes
simplex virus infection in patients with AIDS, and suggested that the company
conduct additional studies.
In a press release, Gilead said that the FDA determined that data from a
placebo-controlled Phase I/II clinical study was not sufficient to support market
clearance, after reviewing Gilead's new drug application.
Gilead said that its NDA application included safety and efficacy data from a single,
Phase I/II placebo-controlled study in 30 AIDS patients with refractory herpes
lesions, who were randomly assigned to receive either treatment with Forvade at
one of two dose levels or placebo once daily for five days.
''At two scientific conferences in 1996, clinical investigators presented data from the
Phase I/II study that demonstrated a statistically significant treatment effect with
Forvade versus placebo in the healing of the refractory lesions, cessation of viral
shedding and reduction in lesion-associated pain,'' Gilead said.
The company added that it plans to work with the FDA to determine what
additional information would be necessary for approval. ''While these discussions
are ongoing, we will continue to make Forvade available through an ongoing
expanded access program in the United States,'' Gilead said.
Gilead, Foster City, Calif., is a pharmaceutical company.
(END) DOW JONES NEWS 05-06-97
11:17 PM
Company Symbols: GILD |
