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
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
