ChemDiv chemistry of cures

Just three months after the FDA rejected the new Brilinta bloodthinner from AstraZeneca, France is now reportedly giving the drugmaker a hard time as well. Even though the European Medicines Agency already endorsed the treatment, the HAS health technology assessment agency in France has decided the med has an unfavorable risk/benefit profile, which puts a halt to final pricing talks and a product launch, according to an investor note from Sanford Bernstein analyst Tim Anderson.

AstraZeneca, he writes, has confirmed that its application was withdrawn in France, where the drug was to be called Brilique. This is an issue for the drugmaker. Even though the EMA decision applies to 27 countries, France is “one of the largest markets in developed Europe for these types of drugs, accounting for nearly one third of the market share of anti-platelet agents in Europe,” he writes.

Although Anderson adds AstraZeneca plans to resubmit additional info later, it remains unclear whether a new analysis of existing data or new data will be required. As Anderson points out, “the former is easy to do, the latter is not.” And this matters, he continues, because Brilinta “has generally been viewed by the investment community as AstraZeneca’s most important new drug.”

Meanwhile, Brilinta faces another FDA approval date in July. The problems in France further cloud the outlook. First, some background: the FDA initially rejected Brilinta - by way of a complete response letter last December- after a trial compared the treatment to Plavix in 18,624 patients in 43 countries, who were being treated for a blocked artery or heart attack. The results showed the med reduced heart attacks, strokes and cardiovascular death 16 percent compared with Plavix after a year’s treatment. And all patients were given aspirin. But about 9 percent of the patients - all of whom were from the US - saw no benefit, stumping an FDA advisory panel (back story).

“We have expected that Brilinta will be approved in the US at its July 20th, 2011, PDUFA date but with cautionary language in the product label describing the US patient findings,” Anderson writes. “However, if French regulatory authorities have turned down the drug, the odds of a negative US ruling would seem to increase at least slightly. Among the things that concerned French regulatory authorities were the side effect profile of Brilique (including dyspnea and bradycardia) and the finding from the US data subset. How much will US regulators continue to struggle with the same?”

* UPDATE: The French transparency commission met in January and sought more information about the drug which, as noted above, will be provided in the coming months, according to Laurie Casaday, global brand communications director for Brilinta. She maintains, however, this commission does not issue regulatory approvals and, therefore, the med was not rejected for usage. And so we have altered the original headline, which indicated the med was rejected. Meanwhile, AstraZeneca has responded to the December complete response letter to the FDA.

Source: http://www.pharmalot.com
Image source: http://i.dailymail.co.uk