The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme. Kynamro was approved as an orphan drug, which…

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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 patients with PAD. Current treatments include exercise, drug…

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The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) System from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided by X-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage…

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This week’s topics include the safety risks of drugs that have gone through the FDA’s expedited approval program, a Framingham Heart Study paper on aortic stiffness in the elderly, and using CMR to detect previously undetected MI in older adults.

The FDA announced today that it has 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 U.S. by Eisai. Lorcaserin is indicated for use in obese adults (BMI 30 or above), or…

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The FDA approval of TAVR and the design of postmarketing surveillance involved a remarkable degree of collaboration and cooperation among the stakeholders. What to do while we wait for data to accumulate?

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 companies reported…

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Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI. The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI…

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I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons…

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The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers,…

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