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J&J (JNJ) Gets FDA Approval for Xarelto Label Expansion


Janssen, a subsidiary of Johnson & Johnson JNJ, announced that the FDA has approved the label expansion of its blood thinner, Xarelto. The drug is now approved for reduction in risk of major cardiovascular (“CV”) events including CV death, myocardial infarction (“MI”) and stroke, in patients with chronic coronary or peripheral artery disease (CAD/PAD).

With approval for the new vascular indication, Xarelto will be the only Factor Xa inhibitor indicated for these patient groups.With this approval, Xarelto is approved in six indications. The company received approval for a similar indication in Europe in August.

Shares of J&J have underperformed the industry year to date. The stock decreased 4.2% as against the industry’s 5.6% gain during the period.

The approval was based on positive results from a phase III study – COMPASS. The study evaluated Xarelto (rivaroxaban, 2.5 mg twice-daily) in combination with aspirin (100 mg once daily) versus aspirin alone in CAD/PAD patients. Data from the study showed that Xarelto/aspirin combination reduced the combined risk of cardiovascular death, stroke and heart attack by 24% in patients with stable CAD/PAD compared with aspirin alone. The findings also showed a massive 42% decrease in any stroke, 22% fall in CV death and 14% reduction in heart attack.

However, the risk of major bleeding was found to be significantly higher in patients receiving treatment by Xarelto/aspirin regimen.

The COMPASS study is a part of the ongoing EXPLORER clinical research program, which is evaluating Xarelto in eight new indications including CV risk.

Notably, Xarelto has been developed by J&J in partnership with Bayer AG BAYRY. The drug is available in more than 80 countries and is marketed by Bayer outside the United States.

Per the company’s press release, CAD is found in 16.5 million people while PAD has affected 10 million people in the United States. Therefore, approval of Xarelto for these additional patient population will provide the company access to a huge market. The drug already enjoys blockbuster status and generated $1.3 billion in sales in the first half of 2018.

Zacks Rank & Key Picks

J&J currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the same space are Roche Holding AG RHHBY and AstraZeneca PLC AZN, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Roche’s earnings per share estimates have increased from $2.14 to $2.22 for 2018 and from $2.15 to $2.28 for 2019 over the past 60 days.

AstraZeneca’s earnings per share estimates have increased from $1.67 to $1.68 for 2018 and from $1.88 to $1.89 for 2019 over the past 60 days. The company came up with positive earnings surprises in all the last four quarters with an average beat of 119.85%.

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