US Department Of Justice Ends Investigation Of AstraZenca Trial Reply

AstraZeneca announced today that the US Department of Justice has ended its investigation into alleged misconduct associated with the pivotal PLATO trial. The company said it had fully cooperated with the investigation, which began in October of 2013.

Click here to read the full post on Forbes.

 

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UK Politician Urges More Use Of Ticagrelor To Preserve AstraZeneca Jobs In UK 3

Use it or lose it. A UK politician is urging the National Health Service (NHS) to increase use of the antiplatelet drug ticagrelor (trade name Brilinta in the US, Brilique and Possia in the EU) in order to prevent the loss of British jobs.

Like nearly all the major pharmaceutical companies, AstraZeneca has been fighting a difficult cycle of patent expirations and unsuccessful new drugs, leading to repeated rounds of layoffs. But, according to the Manchester Evening News, the UK-based company, with the help of UK politicians, is  seeking to turn lemons into lemonade. Science Minister David Willetts is lobbying the National Health Service (NHS) “to increase its use of an AstraZeneca heart medicine, amid mounting political concern about the drugs company’s commitment to British jobs.

The minister, according to the paper, “has urged health officials to accelerate the uptake of Brilique [ticagrelor], a blood thinner used to treat patients suffering from severe angina or heart attacks, which has sold poorly despite winning a green light from the NHS’s cost-effectiveness watchdog in 2011.

AstraZeneca said although it invests heavily in producing new drugs in this country, it’s difficult to persuade primary healthcare trusts to adopt new costly medicines.

The group added: “Despite this recommendation and the NHS target of reducing the mortality rate from cardiovascular disease, it is currently only routinely available to patients in some parts of England.

“We share the NHS and the Government’s objective of broadening patient access to innovative medicines and continue to engage in dialogue.”

Hat tip: Lisa Jarvis (@lisamjarvis) and Matthew Herper (@matthewherper)

Ticagrelor Joins Clopidogrel And Prasugrel In Updated NSTEMI Guidelines Reply

Ticagrelor (Brilinta, AstraZeneca) gains equal standing with prasugrel (Effient, Lilly) and clopdiogrel in the newly released focused update of the ACCF/AHA guidelines for unstable angina and non-ST-elevation myocardial infarction (NSTEMI). The change had been widely anticipated since last year’s FDA approval of ticagrelor.

“We have put it on equal footing with two other antiplatelet medications, clopidogrel and prasugrel,” said Hani Jneid, the, lead author of the update, in a press release issued by the AHA.

As part of the standard of dual-antiplatelet therapy (DAPT), aspirin should be given immediately to patients with unstable angina and NSTEMI. Aspirin use should be continued for “as long as it is tolerated.”

The document offers a highly detailed, near-Talmudic analysis of the literature, with a great deal of attention devoted to analysis of the  TRITON-TIMI 38 trial of prasugrel and the PLATO trial of ticagrelor. Overall, the committee concluded:

This guideline explicitly does not endorse one of the P2Y12 receptor inhibitors over the other.

However, based on data from the trials, the document provide ssome advice about the selection of the P2Y12 receptor inhibitors in specific situations, and related issues involving clopidogrel resistance.

–Because prasugrel was administered only after PCI had been planned, the writing group “does not recommend that prasugrel be administered routinely to patients with UA/NSTEMI before angiography.”

–The writing group cautions “clinicians about the potential increased bleeding risks associated with prasugrel and ticagrelor compared with clopidogrel in specific settings and especially among the subgroups identified in the package insert and clinical trials.”

–The document reviews at length the issue of clopidogrel resistance, but concludes “there is little information about the use of strategies to select patients who might do better with newer P2Y12 receptor inhibitors.”

–On genotype testing for loss-of-function CYP2c19 alleles: “On the basis of the current evidence, it is difficult to strongly recommend genotype testing routinely in patients with ACS, but it might be considered on a case-by-case basis, especially in patients who experience recurrent ACS events despite ongoing therapy with clopidogrel.”

–On platelet function testing: “any strong recommendation regarding more widespread use of such testing must await the results” of ongoing trials…. the prudent physician should maintain an open yet critical mind-set about the concept until data are available…”

–On the use of proton pump inhibitors and clopidogrel: “The expert consensus statement does not prohibit the use of PPI agents in appropriate clinical settings, yet highlights the potential risks and benefits from use of PPI agents in combination with clopidogrel.”

Click here to read the press release from the AHA…

FDA Approves Generic Clopidogrels As Plavix Loses Patent Protection 1

For the second time in the past six 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, Lipitor (atorvastatin), another cardiology mainstay, went off patent, though it wasn’t until earlier this month that multiple generics became available.

The FDA said that it had approved 300 mg formulations of clopdiogrel from Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals and 75 mg formulations from Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals.

In recent years the FDA approved two newer antiplatelet drugs that had been designed to take over the central role of Plavix in treating acute coronary syndromes. However, these drugs, prasugrel (Effient) and ticagrelor (Brilinta) have been struggling in the marketplace, and at this point appear very unlikely to command a significant share of the market.
Click here to read the FDA press release…

The Medicines Company Collaborates with AstraZeneca To Sell Brilinta (ticagrelor) Reply

The Medicines Company will collaborate with AstraZeneca to help sell Brilinta (ticagrelor), AstraZeneca’s struggling oral antiplatelet drug. The collaboration is the first stage of  “a global collaboration for acute ischemic heart disease compound” announced by the two companies today.

AstraZeneca will pay $15 million per year for The Medicines Company’s Brilinta-related sales activities, scheduled to begin in May. The two companies also plan to collaborate on two other drugs from The Medicines Company, Angiomax (bivalirudin), the direct thrombin inhibitor, and cangrelor, an acute intravenous antiplatelet agent. Details of these collaborations have not yet been established.

Like many other large pharmaceutical companies, AstraZeneca has been seeking new sources of revenue after the expiration of patents for many of its key drugs. Initial hopes that Brilinta would provide a much-needed boost to the company have so far not been realized. The Medicines Company has also sought to find a successor to Angiomax, which has been the company’s mainstay.

Click here to read the press release from AstraZeneca and The Medicines Company…