Portola: The FDA Approves Bevyxxa

After years of spending efforts in creating and developing its pipeline products, Portola (PTLA) has just been granted a U.S. Food and Drug Administration’s (FDA) approval of its Prior Approval Supplement (PAS) for the anticoagulant product Bevyxxa® (betrixaban). The product is approved ahead of its scheduled January 30th action date, which enables the release and distribution of its product inventory.

Bevyxxa® is a factor Xa inhibitor approved on June 23, 2017 as a single-drug regimen for the prevention of VTE in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.  

Bill Lis, chief executive officer of Portola said among other statements, “As Bevyxxa is first and only anticoagulant approved as a single-drug regimen administered in the hospital and following discharge for a treatment duration of 35-42 days, Bevyxxa has the potential to impact public health in the U.S. and beyond, if approved in other countries….”

Portola plans to initiate commercial launch in early January 2018.

The firm will provide an update during the next investor presentation and webcast, scheduled for Tuesday, January 9 (7:00 am PT/10:00 am ET).

For Important U.S. Safety Information for Bevyxxa (betrixaban) capsules and the limitations of this product click the following link: www.bevyxxa.com 

Prohost Comments

This is a very important milestone in the life of Portola as the firm moves from development-stage biotech firm into revenue-generating firm. Bevyxxa is important. It is a  factor Xa inhibitor anticoagulant that is approved as a monotherapy for the prophylaxis of pulmonary embolism in hospitalized patients and and following discharge for a treatment duration of 35-42 days.

Increasing our enthusiasm towards  Portola is that it  expects another approval in one, or two months, but maybe a shorter period of its product Adnexanet Alpha. The product is a modified human protein designed to reverse the anticoagulant actions of factor Xa inhibitors anticoagulant drugs. The firms who have approved factor Xa are in great need for it as the antidote that can stop the bleeding that could be life-threatening for patients on these drugs in case they are subjected to injuries or they need emergency surgeries.

As we mentioned above, some of these these anticoagulant products are approved and although they have many advantages over Coumadin, many physicians are hesitating to prescribe them unless  an antidote becomes available.

Here we are. It is Portola’s drug Adnexanet Alpha  that will save thiese firms and protect the users of these anticoagulants against pulmonary embolism that are life-threatening. 

This is Terrific news for Portola.

Prohost added PTLA to its Portfolio on 2/22/14 at $26,65.  PTLA closed today at $50.99 UP $3.39. 

The best is yet to come.

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