Pravastatin/aspirin combo
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee, at July 18 meeting, recommends approval of co-packaging of 20, 40 and 80 mg doses of Bristol-Myers Squibb's Pravachol (pravastatin) with 81 and 325 mg doses of aspirin for "long-term management to reduce the risk of cardiovascular events in patients with clinically evident coronary disease." The committee had previously voted against approval of a 40 mg pravastatin dose with 81 and 325 mg of aspirin because of the inability to titrate pravastatin, as well as concerns about the potential for excess use of aspirin and the resulting risk of bleeding. BMS also is developing a single tablet version of the combinatio
You may also be interested in...
Bristol Pravigard PAC
Bristol-Myers Squibb's Pravigard PAC clears FDA June 24, making it the first aspirin co-packaged product for reducing the occurrence of serious cardiovascular events. The Pravachol (pravastatin)/buffered aspirin combo will launch in August at the same average wholesale price as Pravachol to discourage patients from purchasing the treatments separately. FDA notes Pravigard PAC's convenience and potential for increased compliance in a June 25 "Talk Paper." BMS also is developing a single tablet version of the combination (1Pharmaceutical Approvals Monthly Aug. 1, 2002, In Brief
Can Organovo Leverage Its Solid Phase II Data In MASH?
Cash-limited Organovo has an FXR agonist showing competitive efficacy and tolerability in MASH, but may need a partner to move forward in that disease as it may be prioritizing its IBD program.
Cullinan Changes Tracks, Moving Lymphoma Bispecific Into Autoimmune
The company will discontinue its trial of the CD19-directed bispecific CLN-978 in NHL and develop it in inflammatory diseases, where it could have an edge over CAR-Ts.