US FDA extends review of Pfizer's Fablyn until January
This article was originally published in Scrip
Executive Summary
The US FDAhas extended the review period for Pfizer's selective oestrogen receptor modulator (SERM), Fablyn (lasofoxifene), by three months until January to analyse complete five-year data from the pivotal PEARL study, the company said. In September an advisory panel endorsed approval of Fablyn for the treatment of osteoporosis in women. Committee members generally recommended the SERM for second-line use owing to safety issues raised during clinical trials, including increases in all-cause mortality, thromboembolic events and gynaecological problems. At the time of the meeting preliminary five-year data from the 8,556-patient, placebo-controlled PEARL study were available, but a final report had not been submitted to the agency. The FDA concluded that three-year PEARL data demonstrated lasofoxifene was effective in significantly reducing the risk of new or worsening radiographic vertebral fractures.