Two PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha), each get their day before an FDA advisory committee this week. If approved, dose and price are likely to be deciding factors in how the drugs are used, Reuters reports.
A formulation of cyclosporine (CicloMulsion) failed to improve the primary composite endpoint of mortality, heart failure hospitalization, and left-ventricular remodelling by preventing reperfusion injury in ST-segment elevation myocardial infarction in the phase III CIRCUS trial.
Should clopidogrel (Plavix) be considered an essential medication for world governments to subsidize access to, as is the case for aspirin and simvastatin? This group says yes.
FDA recalls and warnings:
- Four product codes of Baxter’s Vascu-Guard Peripheral Vascular Patch are being recalled because new packaging made it hard to distinguish the smooth and rough surfaces of the patch, which risks vessel thrombosis or embolism if oriented incorrectly with the rough side toward the bloodstream.
- A class II recall was issued for 166 bottles of the ACE inhibitor captoprilmanufactured by Wockhardt for violations of good manufacturing practices.
- A warning letter was also issued announcing that the plant making Insightra Medical’s intra-aortic balloon catheters and inguinal hernia implants is out of compliance with good manufacturing practices.
The FDA also okayed restarting the clinical trial for St. Jude Medical’s Portico transcatheter aortic valve, which had been put on hold last year over concerns about reduced leaflet mobility and leaflet thickening.
The early-phase trial of investigational heart failure treatment cimaglermin alfa has been suspended due to liver toxicity.