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FDA Refuses Xarelto Uncontrolled bleeding anticoagulant

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The US Food and Drug Administration has decline the approval of Portola Pharmaceuticals’ (NASDAQ: PTLA) anticoagulant antidote product for uncontrolled bleeding linked to blood thinners including Xarelto (rivaroxaban) and Eliquis (apixaban).As a result company’s shares fell down by a third. The company share was $23.69, but on the past Wednesday it’s fell down to 11%. On 18th of august in pre-market trading the stock was 17.7% lower at $19.50.The FDA requested the Pharmaceuticals’ company for more information about the product before approval.

Xarelto associated with severe adverse events include internal bleeding, fatal brain and stomach bleeds. There is allegedly no antidote to stop uncontrolled bleeding, which can lead Xarelto to cause someone to bleed to death. The company stated that at present there is no reversal agent for uncontrolled bleeding linked to these drugs. Anticoagulation is needed due to life-threatening or uncontrolled bleeding cause by the drugs. But, last year the FDA granted accelerated approval to Boehringer Ingelheim’s Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

A major reason for the increased risk of bleeding to death on Xarelto appears to be linked to the lack of an approved reversal agent, as there is no safe and effective antidote available that doctors can use to quickly stop hemorrhaging that may develop. In addition, important information about the lack of an antidote was buried within the prescribing information. Studies have also suggested that the drug makers may have reduced the risk of patients dying on Xarelto from uncontrollable bleeding if they had provided stronger warnings and recommended blood monitoring during treatment.

According to a statement by Bill Lis, the chief executive officer of Portola, he said “Because AndexXa addresses an urgent unmet medical need; we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps. Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative, “We plan to meet with the FDA as soon as possible.”

Complete Response Letter by FDA

On 17th of August the FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). The (CRL) states that the agency needs additional information on the drug’s manufacturing and clarify that it needed to review changes Portola made to its post-marketing commitments.

AndexXa’s Phase III clinical trial data showed that AndexXa (andexanet alfa) rapidly reversed the anticoagulant effect of Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) by 93.5 percent, and sustained a high level of efficacy across the two-hour infusion period. According to a statement the company expects to resubmit its application before the end of the year.

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The manufacturers placed their desire for profits before consumer safety by failing to fully explore all potential reversal agents before introducing the medication. Many patients who suffered bleeding-related injuries, strokes, pulmonary embolisms, deep vein thrombosis, and heart attacks have sued. Lawsuits accuse the drug manufacturers of promoting blood thinner as an easy to use and monitor anticoagulant.

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