Portola Pharmaceuticals Inc. (NASDAQ:PTLA) shares lost almost 11% after the company announced that it has received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for AndexXa (andexanet alfa).
We note that AndexXa is being developed for patients treated with a direct (Eliquis, Xarelto, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
In the letter, the FDA has requested for additional information related to product manufacturing. It has also asked for more data to support the inclusion of edoxaban and enoxaparin in the product label.
In its press release, the company has revealed that it will meet the FDA as soon as possible.
Meanwhile, Portola continues to evaluate AndexXa in a phase IIIb/IV (ANNEXA-4) study in patients receiving Eliquis, Xarelto, edoxaban or enoxaparin, who have an acute major bleeding problem. We remind investors that AndexXa enjoys Orphan Drug Status in the U.S.
The FDA’s CRL will be a huge setback for Portola as the company is highly dependent on AndexXa for growth. A positive response from the agency would have enabled Portola to launch its first drug in the market.
Note that with no currently approved antidote for Factor Xa inhibitors, there is high unmet need for the same in the market.
According to information provided by the company, in 2015, over 80,000 U.S. patients treated with oral Factor Xa inhibitors were admitted to the hospital due to bleeding. Moreover, it has been estimated that over 100,000 patients taking the injectable Factor Xa inhibitor enoxaparin in the U.S. could benefit from an antidote each year.
Going ahead, we expect investor focus to remain on further details on the regulatory aspect of AndexXa.
Portola currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Geron Corporation (NASDAQ:GERN) , Anika Therapeutics Inc. (NASDAQ:ANIK) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Each of these stock sports a Zacks Rank #1 (Strong Buy).
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