FDA launches safety review of J&J's Regranex

6 April 2008

The US Food and Drug Administration has launched a safety review after receiving study data that showed an increased risk of cancer in patients with diabetes who applied Johnson & Johnson's topical growth factor Regranex directly to their foot and leg ulcers.

The evaluation was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those prescribed the agent three or more times, there was an increase in the number of patients who died as a result of cancer There was not enough information to say whether there was an increase in the number of patients that developed new cancers, the agency noted. At this time, the FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with the J&J drug. The recombinant platelet-derived growth factor-based product was first approved in the USA in 1997 and has also been registered in Europe, and other countries including Canada, Argentina, Brazil, Israel, Mexico and Singapore.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight