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.
You may also be interested in...
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects
CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.