Please ensure Javascript is enabled for purposes of website accessibility

Losing the Battle and the War

By Brian Orelli, PhD – Updated Apr 7, 2017 at 3:35PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

FDA turns down Johnson & Johnson's Xarelto, and more competition could be on the way.

Johnson & Johnson's (NYSE: JNJ) investors could use a little heart mending, after the Food and Drug Administration shot down the company's application to expand the use of Xarelto to patients with acute coronary syndrome.

As is typical with large pharma, Johnson & Johnson didn't give many details about the complete response letter, the agency's euphemism for a rejection. But we can hazard a guess based on the FDA advisory committee meeting.

That committee voted six to four, with one abstention, recommending that the drug not be given the expanded indication, in large part because a large fraction of data from the subjects in the clinical trials wasn't available because of a large numbers of dropouts.

Assuming that's the issue, solving that problem won't be easy. Running another large trial will take years and a lot of added expense. If it was easy to track down the dropouts and figure out what happened to them, you'd think that Johnson & Johnson would already have done that.

Xarelto is still approved to reduce the risk of blood clots after certain surgeries, and for atrial fibrillation, but it won't be able to compete with AstraZeneca's (NYSE: AZN) Brilinta and Eli Lilly's (NYSE: LLY) Effient,  for acute coronary syndrome patients, until it satisfies the FDA.

Johnson & Johnson's investors eyes should now turn to Pfizer (NYSE: PFE) and Bristol-Myers Squibb's (NYSE: BMY) blood thinner Eliquis, which is expected to receive an FDA decision for its use in atrial fibrillation next week. If the FDA signs off on that drug, which is widely expected, Xarelto will have added competition from a drug that seems to have better data supporting its use in atrial fibrillation.

Johnson & Johnson has lost the acute coronary syndrome battle for now. Unless the FDA comes to its rescue and turns down Eliquis, it looks like the health-care conglomerate might be losing the blood thinner war.

Fortunately, Johnson & Johnson is a diversified company, and can handle the hit. It's one of the nine companies featured in the Fool's free report, "Secure Your Future With 9 Rock-Solid Dividend Stocks." Find out what the other eight are by following this link.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Johnson & Johnson and Pfizer, and have recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy.

We Fools may not all hold the same opinions, but we all believe that
considering a diverse range of insights makes us better investors.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.