Pfizer Gets Approvable Letter for AIDS Drug, Scraps Cancer Trials
Pfizer said after markets closed Wednesday that U.S. health regulators will approve its novel AIDS drug called maraviroc once certain conditions have been met, although the world's biggest drugmaker did not elaborate on what was necessary to obtain an outright approval.
Pfizer received a so-called approvable letter from the Food and Drug Administration for the twice-a-day pill that is the first drug designed to keep the HIV virus that causes AIDS from entering healthy immune cells. Older AIDS medicines attack the virus itself.
The company said it was in discussions with the FDA to address the agency's outstanding questions and finalize the product labeling as soon as possible.
Earlier Wednesday, Pfizer said it has ended trials of PF-3512676 in combination with cytotoxic chemotherapy as a treatment for lung cancer.
The company said this includes two Phase 3 and two Phase 2 clinical trials.
Pfizer said an interim analysis of the Phase 3 trials by an independent data safety monitoring committee (DSMC) showed there was no evidence that PF-3512676 produced additional clinical efficacy over that achieved with the standard cytotoxic chemotherapy regimen alone.
"The DSMC concluded that the risk-benefit profile did not justify continuation of the trials," the company said.
Pfizer said it licensed PF-3512676 from Coley Pharmaceutical Group in 2005. Coley shares nosedived more than 55% Wednesday.