Exubera Gone, But Not Forgotten: FDA Imposes REMS, Mandates Trials
This article was originally published in RPM Report
Executive Summary
Pfizer is no longer marketing inhaled insulin, but the regulatory work continues. FDA makes clear that any future inhaled insulin products will need a risk management plan and mandatory post-marketing studies.
You may also be interested in...
Pfizer’s Unusual Contribution to the Afrezza Review
FDA’s portion of the advisory committee review of MannKind’s inhaled insulin included an unusual number of separate presentations (five) – and one especially unusual review based on a slide presentation from the first inhaled insulin sponsor, Pfizer.
Ghosts of Exubera Haunt Afrezza As Lung Function, Cancer Concerns Weigh Heavily
FDA advisory committee review of MannKind’s inhaled insulin revisits safety issues that troubled Pfizer’s first-of-its-kind product, including a potential lung cancer risk and declines in pulmonary function.
The Year of the Unpartnered Blockbuster? High Profile Applications Raise Big Questions
Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight.