CardioExchange Archive

May 17th, 2012

FDA Approves Generic Clopidogrel as Plavix Loses Patent Protection

Larry Husten, PHD

For the second time in the past 6 months, a cardiology mainstay drug has lost patent protection and gone generic. Today, the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November, the best-selling drug of all time, […]

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May 11th, 2012

A ‘Brilinta’ Theory on Why Ticagrelor Doesn’t Work as Well in the U.S.

Harry Peled, md

Harry Peled wonders whether intermediate-dose aspirin may simply be so effective that it obviates the need for a P2Y12-receptor antagonist.

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December 17th, 2010

FDA Delays Approval of Ticagrelor

Larry Husten, PHD

Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the […]

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September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

Larry Husten, PHD

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA […]

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August 6th, 2010

Three Questions about Ticagrelor: Part 4 — Bob Harrington

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the […]

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August 5th, 2010

Three Questions about Ticagrelor: Part 3 — Jonathan Halperin

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used in the […]

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August 4th, 2010

Three Questions about Ticagrelor: Part 2 — Mori Krantz

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US were found to have no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses […]

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August 3rd, 2010

Three Questions about Ticagrelor: Part 1 — Sanjay Kaul

Sanjay Kaul, MD

PLATO is one of the most impressive trials in recent years, demonstrating substantial benefits for ticagrelor over clopidogrel in a wide population of ACS patients. However, patients enrolled in the US showed no benefit from ticagrelor, and experts have been unable to agree on a cause. Possible factors could include much higher doses of aspirin used […]

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