This could be much-needed good news for the beleaguered drugmaker, which has suffered one setback after another this year trying to win FDA approval for new drugs. Its forthcoming Aprela pill, which combines estrogen with an osteoporosis med, reduced hot flashes by 80 percent, according to results of a study released this evening.
But there's a catch - the osteoporosis drug is another Wyeth med called Viviant. And the FDA last April delayed approval and requested more data. Wyeth provided more info in July, but the outcome is uncertain. "Before you can even look at Aprela, you gotta look at Viviant,'' Mike Krensavage, an analyst with Raymond James, tells Bloomberg News. If the FDA rejects Viviant, he says, it's possible Aprela won't win clearance either.
There's another hiccup, too. A year ago, Wyeth announced plans to seek FDA marketing approval this year. But now the drugmaker says that move won't be made until at least March. Delays happen, of course, in drug development. But given Wyeth's recent problems, a few months is significant - in money and credibility. By March, Bernie Poussot will be ceo. Can he make a difference? Hard to say. He's been the No. 2 exec behind retiring ceo Bob Essner for the last few years, so it's not clear what, if any, new thinking he'll bring to solving the problems.
In the company-funded study presented at the North American Menopause Society, Aprela's 80 percent reduction in hot flashes after 12 weeks compared with 51 percent for a placebo, based on Phase III data. With the placebo, hot flashes fell by half after 30 days, about twice as long as Aprela.
Wyeth's director of women's health, Ginger Constantine, tells Bloomberg that Aprela is a "major paradigm shift in menopause therapy" because it appears to curb hot flashes and strengthen bones without raising the risk of breast or uterine cancer. Wyeth forecasts Aprela sales of $2 billion a year, offsetting a plunge in revenue from Premarin and Prempro after studies in 2002 linked the drugs to cancer and heart attacks.
"It's the holy grail to find a drug that treats hot flashes as well as estrogen without the risks associated with hormone therapy," Michelle Warren, the Wyeth-Ayerst professor of women's health at Columbia University Medical Center in New York, tells the wire service. "If Aprela is as good as Wyeth says it is, and the data bears this out, I would use this drug as first-line therapy." Full disclosure: Warren reportedly wasn't involved in the study, but is a Wyeth consultant and a speaker for the drugmaker.