November 25th, 2013

FDA Reprimands 23andMe, Grants Breakthrough Status to Factor Xa Inhibitor, and Approves Promus Premier Stent

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe:

FDA Halts 23andMe Personal Genome Test: The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.  The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response. The FDA wrote that

false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by INR management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”

The FDA said the company had failed to address issues raised by the FDA in 2012 and was therefore withdrawing the earlier 510(k) approval of the test. The unusually harsh FDA letter says that more than five years after 23andMe began marketing PGS

you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”


FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote: Portola Pharmaceuticals said that the FDA had granted a breakthrough therapy designation for its investigational Factor Xa inhibitor, andexanet alfa. The designation is intended “to expedite the development and review of drugs for serious or life-threatening conditions,” according to the FDA, which requires “preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.”

Early studies have shown that andexanet alfa can reverse the anticoagulant effect of Factor Xa inhibitors. Phase 2 proof-of-concept studies of andexanet alfa have been completed with apixaban (Eliquis, Pfizer and BristolMyers Squibb) and rivaroxaban (Xarelto, Johnson & Johnson). Additional studies are being completed with enoxaparin and betrixaban, according to the company.

“The FDA’s decision to designate andexanet alfa as a breakthrough therapy reaffirms the urgent need for an antidote to Factor Xa inhibitors, and we believe it demonstrates that andexanet alfa’s properties and data distinguish it from currently used agents or others in development,” said William Lis, the CEO of Portola, in a press release.


FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System: Boston Scientific announced that it had received FDA approval for the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System. The company said that the first implantation was scheduled to be performed by Martin Leon at Columbia University in New York City.

“Perhaps the most impressive benefit of the Promus PREMIER Stent System is its unparalleled visibility, which combined with enhanced customized stent architecture, leads to an advance in currently available durable polymer DES,” said Leon, in a Boston Scientific press release.



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