The FDA’s Center for Drug Evaluation and Research (CDER) informed Pertola (PTLA that it does not plan to hold an Advisory Committee meeting for its Product betrixaban.
What is betrixapan?
Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway.
Why it is used?
Betrixapan is used to prevent thrombosis, which is life-threatening. Results from clinical trials showed that betrixapan demonstrated clinical benefit without the risk of major bleeding seen with other agents in the same class.
Betrixaban has a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that reduces anticoagulant variability, low renal clearance, and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.
The FDA has granted bexitrapan Fast Track-designated therapy. The the NDA is now under priority review by the FDA for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
What does this mean?
Acute medically ill patients are those who are hospitalized for serious medical conditions that put them at increased risk of venous thromboembolism (VTE).
What is VTE?
VTE is a serious and potentially life-threatening blood clot (thrombus) that could occur in a deep vein, hence called deep vein thrombosis (DVT), or in the lungs, thus called pulmonary embolism (PE). Thrombosis and embolisms are major causes of morbidity and mortality, which can be prevented if treated.
What about overseas?
In the European Union, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is also reviewing the Marketing Authorization Application for betrixaban under a standard 210-day review period.
The market for venous thromboembolism (VTE) is tremendously large. Millions of people belong to the acute medically ill patients who are at risk of developing VTE. So, the approval and marketing of bexitrapan will generate a large revenue to Portola.
FDA decision not to hold an Advisory Committee meeting for bexitrapan should by no mean be interpreted as bad news. When it comes to the FDA intention to deny approval of a drug it announces its decision directly to the firm that owns the drug. In case the FDA sees something important missing, or unclear in a firm’s NDA, it sends to the firm what is known as a Complete Letter asking it to provide the missing part or clarify the unclear part.
In most cases, not holding an advisory committee suggests that the FDA is ready and willing to approve a product without the need for an external opinion, which is good news.
We said this because after rallying for a couple of weeks, the stock has given back some of its gains to profit-taking, which made some investors believe that the market is negatively interpreting the news coming from the FDA.
Previously Announced News
A few days before the FDA announced the news mentioned above, Portola announced that it has signed a $150 million royalty agreement with HealthCare Royalty Partners (HCR). Under the terms of the agreement, Portola received $50 million at closing and may receive an additional $100 million upon The FDA approval of AndexXa™ (andexanet alfa) in exchange for a tiered, mid-single-digit royalty based on worldwide sales of the agent.
Portola declared that the HCR financing will help fund its operations in a non-dilutive manner and will also help it launch this potentially life-saving drug. We remind that andexanet alfa, which is FDA-designated Breakthrough Therapy, is a potential antidote for Factor Xa inhibitors.
A few firms have Factor Xa inhibitors on the market. The big problem is that, in contrast with Warfarin, which has vitamin K as antidote, these products have no antidotes, subjecting their users to a profuse bleeding caused either by the Factor Xa inhibitors, or in case of trauma caused by either accidents or by emergency surgeries.
In August 2016, Portola received a Complete Response Letter from the FDA regarding its Biologics License Application for andexanet alfa. The firm expects to resubmit the application in the first half of 2017.
In the EU, the European Medicines Agency is reviewing the Marketing Authorization Application for andexanet alfa.
We appreciate this firm’s science and technological capabilities. An FDA and European approvals of both products during 2017 would be great news for this firm and its shareholders.
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