FDA's Victoza Decision BalancedUnknown Cancer Risk Against Known FDAAA Measures
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s approval of Novo Nordisk’s type 2 diabetes drug Victoza (liraglutide) was a bit surprising for an agency often seen as increasingly conservative, even given that the Jan. 25 decision came with extensive labeling, risk management and mandatory post-market studies focused on the cancer risk.
You may also be interested in...
Out Of The Shadow Of REMS: FDA Review Documents Show Emerging Importance Of Post-Marketing Requirements
Although often overshadowed by the novelty of FDA’s sweeping authority in constructing Risk Evaluation and Mitigation Strategies, examination of agency review documents suggest that the FDA Amendments Act’s other safety innovation, granting FDA the ability to require (i.e., enforce) post-marketing studies, is increasingly important to the approval of NDAs with marginal data on issues of concern.
Out Of The Shadow Of REMS: FDA Review Documents Show Emerging Importance Of Post-Marketing Requirements
Although often overshadowed by the novelty of FDA’s sweeping authority in constructing Risk Evaluation and Mitigation Strategies, examination of agency review documents suggest that the FDA Amendments Act’s other safety innovation, granting FDA the ability to require (i.e., enforce) post-marketing studies, is increasingly important to the approval of NDAs with marginal data on issues of concern.