Avapro and Cozaar for diabetic nephropathy
Bristol-Myers Squibb/Sanofi-Synthelabo's Avapro (irbesartan) and Merck's Cozaar (losartan) share Sept. 17 supplemental approvals for treatment of diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension. Avapro's supplemental approval was based on the IDNT trial, which FDA's Cardiovascular & Renal Drugs Advisory Committee felt did not provide sufficient evidence due to its "modest" p-value. Merck's Cozaar supplement was based on the RENAAL study, which the committee also did not feel was sufficient, as it failed to reach statistical significance. However, the advisory committee was in favor of approval when viewing the data from the two trials in conjunction. The firms reached an agreement to reference each other's studies in the sNDAs. Labeling refers only to their own studie
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.
The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.