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J&J (JNJ)/Bayer Seek Nod for Xarelto for Blood Clots in Kids
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Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Pharmaceuticals announced that it has submitted a new drug application (NDA) for its blood thinner drug, Xarelto (rivaroxaban), seeking approval to treat and prevent blood clots in pediatric patients.
The NDA seeks approval for a body weight-based dosage of an oral formulation or tablet of the factor Xa inhibitor drug for two pediatric indications. One indication is treatment for venous thromboembolism (VTE), a disorder characterized by blood clots, and reduction in the risk of recurrent VTE in children (patients aged below 18 years). The other indication is thromboprophylaxis in patients aged at least two years with congenital heart disease, who are at risk of VTE after a recent Fontan procedure.
The NDA includes data from two phase III studies — EINSTEIN-Jr for treating VTE and UNIVERSAL for thromboprophylaxis. EINSTEIN-Jr study evaluated Xarelto in patients with VTE who have undergone initial parenteral anticoagulant treatment for at least five days.
Following a potential approval, the drug will be the first and only oral factor Xa inhibitor indicated for pediatric patients in the United States. Please note that J&J’s partner in development of Xarelto, Bayer AG (BAYRY - Free Report) received approval for Xarelto in a similar pediatric indication in Canada, Europe and Japan earlier this year.
J&J stated that the current usage guidelines for a standard anticoagulant therapy for treating or preventing VTE in pediatric patients are limited, which leads to ambiguity about doses and regular monitoring. Potential approval of body weight-based dosage of Xarelto will help physicians administer optimal doses, backed by clinical data, to such patients. Moreover, the availability of Xarelto suspension for oral use will considerably reduce the number of injections needed for standard anticoagulation treatment and blood sampling.
Shares of J&J have increased 3.3% year to date compared with the industry’s growth of 6.7%.
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We remind investors that Xarelto is already approved for preventing VTE and VTE related death in adult patients with acute illness, during hospitalization and post hospital discharge. The drug is also approved by the FDA to treat people with atrial fibrillation, a common heart rhythm disorder that increases the risk of stroke. The drug is used to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms. It is also used to reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease.
We note that Pfizer (PFE - Free Report) and Bristol-Myers (BMY - Free Report) are also evaluating the safety and effectiveness of their factor Xa inhibitor drug, Eliquis, in pediatric patients with VTE in an open-label study. Eliquis is also approved for treating DVT, PE and nonvalvular atrial fibrillation. Another factor Xa inhibitor approved for treating different blood clot related disorders is Daichi Sankyo’s Savaysa.
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J&J (JNJ)/Bayer Seek Nod for Xarelto for Blood Clots in Kids
Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Pharmaceuticals announced that it has submitted a new drug application (NDA) for its blood thinner drug, Xarelto (rivaroxaban), seeking approval to treat and prevent blood clots in pediatric patients.
The NDA seeks approval for a body weight-based dosage of an oral formulation or tablet of the factor Xa inhibitor drug for two pediatric indications. One indication is treatment for venous thromboembolism (VTE), a disorder characterized by blood clots, and reduction in the risk of recurrent VTE in children (patients aged below 18 years). The other indication is thromboprophylaxis in patients aged at least two years with congenital heart disease, who are at risk of VTE after a recent Fontan procedure.
The NDA includes data from two phase III studies — EINSTEIN-Jr for treating VTE and UNIVERSAL for thromboprophylaxis. EINSTEIN-Jr study evaluated Xarelto in patients with VTE who have undergone initial parenteral anticoagulant treatment for at least five days.
Following a potential approval, the drug will be the first and only oral factor Xa inhibitor indicated for pediatric patients in the United States. Please note that J&J’s partner in development of Xarelto, Bayer AG (BAYRY - Free Report) received approval for Xarelto in a similar pediatric indication in Canada, Europe and Japan earlier this year.
J&J stated that the current usage guidelines for a standard anticoagulant therapy for treating or preventing VTE in pediatric patients are limited, which leads to ambiguity about doses and regular monitoring. Potential approval of body weight-based dosage of Xarelto will help physicians administer optimal doses, backed by clinical data, to such patients. Moreover, the availability of Xarelto suspension for oral use will considerably reduce the number of injections needed for standard anticoagulation treatment and blood sampling.
Shares of J&J have increased 3.3% year to date compared with the industry’s growth of 6.7%.
We remind investors that Xarelto is already approved for preventing VTE and VTE related death in adult patients with acute illness, during hospitalization and post hospital discharge. The drug is also approved by the FDA to treat people with atrial fibrillation, a common heart rhythm disorder that increases the risk of stroke. The drug is used to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms. It is also used to reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease.
We note that Pfizer (PFE - Free Report) and Bristol-Myers (BMY - Free Report) are also evaluating the safety and effectiveness of their factor Xa inhibitor drug, Eliquis, in pediatric patients with VTE in an open-label study. Eliquis is also approved for treating DVT, PE and nonvalvular atrial fibrillation. Another factor Xa inhibitor approved for treating different blood clot related disorders is Daichi Sankyo’s Savaysa.
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J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>