–Approvals with no strong evidence of efficacy: What could go wrong? The FDA has a big problem. It likes to approve new drugs and devices. Approvals look good politically and allow the FDA to boast each year about their large number of approvals. But when the FDA approves a drug or device that doesn’t work…
FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug
June 30, 2016 by Leave a Comment
Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…
FDA Approves Zilver PTX Drug-Eluting Stent For Peripheral Arterial Disease
November 15, 2012 by 1 Comment
The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent (DES) approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for treating patients with PAD. Current treatments include exercise,…
TAVI: Belgian Researchers Slam Evidence Base And Overuse In Europe
July 31, 2012 by 1 Comment
The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are…
FDA Approves A New Weight Loss Drug, Breaking a 13 Year Drought
June 27, 2012 by Leave a Comment
The FDA announced today that it had approved its first new weight loss drug in 13 years. Lorcaserin, which will be sold under the brand name of Belviq, is manufactured by Arena Pharmaceuticals and will be distributed in the US by Eisai. Lorcaserin is indicated for use in obese adults (BMI 30 or above) or…
FDA Once Again Delays Approval Of Apixaban (Eliquis)
June 25, 2012 by 2 Comments
The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two…
Decision on Apixaban (Eliquis) Pushed Back By Three Months
February 29, 2012 by 1 Comment
Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
February 22, 2012 by 2 Comments
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this…
FDA Approves Medtronic’s Resolute Drug-Eluting Stent for Treatment of CAD, Including Diabetics
February 17, 2012 by Leave a Comment
The FDA has approved the Medtronic Resolute zotarolimus-eluting stent for the treatment of coronary artery disease. The Resolute DES is approved for use in a wide variety of patients, including diabetics. The new stent uses the same drug-and-polymer combination as the popular Resolute Integrity DES. The Resolute clinical trial program enrolled more than 5,000 patients worldwide, a…
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