Johnson & Johnson (JNJ), Bayer Lower after Receiving Adverse Comments About Blood-Thinner, Xarelto
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Johnson & Johnson (NYSE: JNJ) shares are trading lower Tuesday morning, following reports that it, and partner Bayer AG (OTCBB: BAYRY) received adverse comments about its blood-thinner Xarelto (rivaroxaban).
According to reports, the U.S. Food and Drug Administration (FDA) said, in a report released today, that there is "insufficient information about the drug to determine whether it is safe for use with its proposed labeling."
Aiming to combat the irregular heart condition known as atrial fibrillation, JNJ and Bayer are targeting a market of about 2 million patients in the U.S. Xarelto has already won approval to be marketed to prevent blood clots following knee or hip surgery.
The FDA noted that an advisory panel will meet on September 8th to discuss the use of Xarelto further. However, there is no obligation for the FDA to follow the panel's recommendation.
Competitors to Xarelto, according to Bloomberg, are Boehringer Ingelheim GmbH’s Pradaxa, as well as Pfizer (NYSE: PFE) and Bristol-Myers Squibb's (NYSE: BMY) Eliquis (apixaban). Pradaxa is currently approved for use in heart patients, while Eliquis is currently in clinical trials.
JNJ is trading 2 percent lower Monday.
According to reports, the U.S. Food and Drug Administration (FDA) said, in a report released today, that there is "insufficient information about the drug to determine whether it is safe for use with its proposed labeling."
Aiming to combat the irregular heart condition known as atrial fibrillation, JNJ and Bayer are targeting a market of about 2 million patients in the U.S. Xarelto has already won approval to be marketed to prevent blood clots following knee or hip surgery.
The FDA noted that an advisory panel will meet on September 8th to discuss the use of Xarelto further. However, there is no obligation for the FDA to follow the panel's recommendation.
Competitors to Xarelto, according to Bloomberg, are Boehringer Ingelheim GmbH’s Pradaxa, as well as Pfizer (NYSE: PFE) and Bristol-Myers Squibb's (NYSE: BMY) Eliquis (apixaban). Pradaxa is currently approved for use in heart patients, while Eliquis is currently in clinical trials.
JNJ is trading 2 percent lower Monday.
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