Aprela is yet another hormone replacement therapy drug made from conjugated equine estrogen, taken from pregnant mare’s urine. This article leaves the word “equine” out, but does mention the mares, so we congratulate the writer on presenting that item of note.
We excerpt the article below, but we highly recommend you read it in its entirety, as the information is important, especially to women. Jump to full article >>
Cross-posted from the Wall Street Journal
Written by PETER LOFTUS
Pfizer Inc. is preparing to seek U.S. regulatory approval to sell a new menopause drug that could pose an alternative to the company’s older hormone-replacement therapies, which have been tied to safety risks.
However, repeated delays in developing the new drug, Aprela, have raised questions about its potential. Some analysts and doctors question whether regulators will approve it, and Aprela’s market potential could be limited by continued safety concerns about hormone-based drugs.
The New York-based drug maker expects to submit Aprela for Food and Drug Administration approval sometime this year, according to Olivier Brandicourt, president and general manager of Pfizer’s primary-care unit. He discussed Aprela in an interview earlier this month.
Mr. Brandicourt said the drug has the potential to reduce menopausal symptoms such as hot flashes and to prevent bone-thinning osteoporosis, but with a better safety and tolerability profile than older hormone-replacement therapies.
“We think this is a market which is unsatisfied … and if you can bring a hormone therapy which doesn’t have the traditional side effects, we can actually lead that marketplace,” Mr. Brandicourt told reporters at a November meeting.
Many women stopped using hormone-replacement therapies after a large government study, the Women’s Health Initiative, raised safety concerns a decade ago. Continue reading >>