–13 years after ApoA-1 Milano sparked excitement the novel HDL therapy appears to be dead. After 13 years and despite the efforts of 3 separate companies, the novel cholesterol therapy known as ApoA-1 Milano appears to be dead. On Monday afternoon the Medicines Company announced that it had discontinued development of the drug and would…
Pfizer Ends Development Of Its PCSK9 Inhibitor
November 1, 2016 by 1 Comment
–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…
Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers
October 15, 2015 by 3 Comments
Everyone expects that the makers of the new PCSK9 inhibitor cholesterol lowering drugs are going to make billions and billions of dollars from these innovative new drugs. But before that can happen the companies that make the drugs will need to find the patients who will take the drug. To help find these patients a central strategy…
Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
December 5, 2013 by Leave a Comment
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of…
The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT
November 14, 2013 by Leave a Comment
Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…
Faint PRAISE: 13 Year Delay In Publication Of A Major Clinical Trial Sparks Criticism
August 5, 2013 by Leave a Comment
13 years after first being presented the results of the PRAISE-2 trial finally have been published in JACC: Heart Failure. The trial itself is now largely irrelevant to current clinical practice, as the hypothesis it tested has long been abandoned, but the long delay in publication may serve to bring even more awareness to the…
New Anticoagulant Found Safe And Effective In Acute Venous Thromboembolism
June 30, 2013 by 1 Comment
In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at…
Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents
June 21, 2013 by Leave a Comment
After the presentation and publication of the pivotal ARISTOTLE trial, the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9…
Danish Study Finds No Increased CV Risk With Azithromycin In General Population
May 1, 2013 by Leave a Comment
A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls…
Blood Sample Mismatch Leads ‘Anguished’ Authors To Retract Three Lipitor Papers
April 16, 2013 by 1 Comment
Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants. The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns….
The Big Gamble of CETP Inhibitors
January 25, 2013 by 2 Comments
Merck has invested a substantial amount of money on the CETP inhibitor anacetrapib. Chemist and veteran pharma blogger Derek Lowe suspects that the company might as well have plunked the money down in a casino. In a provocative new post, Lowe wonders if big pharma, in its desperation, has abandoned rational research in favor of, essentially,…
FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF
December 28, 2012 by 4 Comments
The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest…
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