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Portola IndexXa's Regulatory Application Validated in the EU
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Portola Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has completed the validation period and accepted to review the company’s Marketing Authorization Application (MAA) for IndexXa (andexanet alfa; U.S. trade name: AndexXa), a Factor Xa inhibitor antidote.
We note that IndexXa is being developed for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and for patients who require urgent or emergency surgery.
The company is seeking a conditional approval of IndexXa through the centralized procedure.
We remind investors that a couple of days ago, Portola received a Complete Response Letter (CRL) in the U.S. for its Biologics License Application (BLA) for AndexXa. The FDA has requested additional information related to product manufacturing and asked for more data to support the inclusion of edoxaban and enoxaparin in the product label. Portola plans to meet with the agency as soon as possible to determine the next steps for AndexXa.
Meanwhile, Portola continues to evaluate andexanet alfa in a phase IIIb/IV (ANNEXA-4) study in patients receiving Eliquis, Xarelto, edoxaban or enoxaparin, who have an acute major bleeding problem. The candidate enjoys Orphan Drug Status in the U.S.
Note that with no currently approved antidote for Factor Xa inhibitors, there is high unmet need for the same in the market. On an annual basis, about 1–4% of patients treated with Factor Xa inhibitors may experience a major bleeding problem. Moreover, an additional 1% of patients may require emergency surgery.
According to information provided by the company, in 2016, about 73,000 patients treated with an oral Factor Xa inhibitor have been estimated to be hospitalized either due to major bleeding problem or due to the requirement of urgent surgery, in five major countries in the EU – France, Germany, Italy, Spain and the UK.
Going ahead, we expect investor focus to remain on further details on the regulatory aspect of the candidate in both the U.S. and the EU.
Portola currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Each of these stock sports a Zacks Rank #1 (Strong Buy).
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Portola IndexXa's Regulatory Application Validated in the EU
Portola Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has completed the validation period and accepted to review the company’s Marketing Authorization Application (MAA) for IndexXa (andexanet alfa; U.S. trade name: AndexXa), a Factor Xa inhibitor antidote.
We note that IndexXa is being developed for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and for patients who require urgent or emergency surgery.
The company is seeking a conditional approval of IndexXa through the centralized procedure.
We remind investors that a couple of days ago, Portola received a Complete Response Letter (CRL) in the U.S. for its Biologics License Application (BLA) for AndexXa. The FDA has requested additional information related to product manufacturing and asked for more data to support the inclusion of edoxaban and enoxaparin in the product label. Portola plans to meet with the agency as soon as possible to determine the next steps for AndexXa.
Meanwhile, Portola continues to evaluate andexanet alfa in a phase IIIb/IV (ANNEXA-4) study in patients receiving Eliquis, Xarelto, edoxaban or enoxaparin, who have an acute major bleeding problem. The candidate enjoys Orphan Drug Status in the U.S.
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Note that with no currently approved antidote for Factor Xa inhibitors, there is high unmet need for the same in the market. On an annual basis, about 1–4% of patients treated with Factor Xa inhibitors may experience a major bleeding problem. Moreover, an additional 1% of patients may require emergency surgery.
According to information provided by the company, in 2016, about 73,000 patients treated with an oral Factor Xa inhibitor have been estimated to be hospitalized either due to major bleeding problem or due to the requirement of urgent surgery, in five major countries in the EU – France, Germany, Italy, Spain and the UK.
Going ahead, we expect investor focus to remain on further details on the regulatory aspect of the candidate in both the U.S. and the EU.
Portola currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Each of these stock sports a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>