Industry To FDA: Rethink Diabetes Drug CV Safety Requirements
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Standards in place under a 2008 guidance should be supplanted with cardiovascular safety requirements tailored to individual drugs, PhRMA and BIO say at a public hearing on interim CV data disclosures.
You may also be interested in...
Biotech Investors Eye Early-Stage Venture Vacuum
Data compiled and analyzed by the Biotechnology Industry Organization and discussed at its recent CEO & Investor meeting in New York begs the question: why aren’t more new biotechs being started when investor and acquirer demand is so high?
FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training
Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.
Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety?
Large outcomes studies showed neither cardiovascular harm nor benefit with BMS/AstraZeneca’s saxagliptin or Takeda’s alogliptin, prompting some commenters to question whether FDA’s blanket approach to CV safety for all antidiabetic agents needs adjustment.