An FDA advisory committee's strong recommendation against approval of cardiovascular risk reduction claims for Merck & Co. Inc.'s Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) on the basis of the IMPROVE-IT trial puts the agency's senior review officials between a rock and a hard place, and possibly searching for an alternate route.
IMPROVE-IT Study: Negative Panel Review Leaves FDA With Tough Choice
Approval of cardiovascular risk reduction claims for Merck's Zetia and Vytorin would fly in the face of advisory committee's recommendations, but rejection would mean the first outcomes study to show CV benefit for a non-statin, LDL-C-lowering agent did not provide substantial evidence.
More from United States
Pink Sheet Podcast: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval Trends
Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.
Speculation that the Trump Administration may "pause" the second negotiation cycle to make changes to the program adds uncertainty to an already challenging scenario.
The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its future are high.
Robert Califf’s final appearance on Capitol Hill as US FDA commissioner, a 5 December Senate hearing focused on the agency’s food and nutrition functions, was an appropriate coda to his tenure and preview of things to come under the Trump Administration.
More from North America
The outgoing FDA commissioner, who placed much of the blame for tough calls on small companies that conduct inadequate clinical programs, defended his policy to not overrule center directors, but added that he did not entirely exclude himself from some of the agency's most controversial drug reviews.
At the J.P. Morgan Healthcare Conference, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA Commissioner Scott Gottlieb warned of threats to public safety.
Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.