Analysts react to FDA panel vote on Johnson & Johnson, Bayer's Xarelto

Analysts on Friday indicated that expanded US regulatory approval of Johnson & Johnson and Bayer's Xarelto (rivaroxaban) to include the prevention of stroke in people with atrial fibrillation is now expected after an FDA advisory panel recommended approval of the drug. Staff documents released ahead of the panel vote had questioned whether the data provided supported the safety and efficacy of the oral anticoagulant in this patient population.

Citi analyst Matthew J. Dodds said he expects the agency to approve the drug in November, although he cautioned that there was also the possibility of a delay. Jefferies analyst Jeffrey Holford agreed, and said it is likely that a small additional trial will be required, which could setback Xarelto's launch by approximately 12 months. However, Mark Purcell of Barclays Capital noted that "the recommendation for approval is potentially a Pyrrhic victory," adding that "the FDA may very well opt for a label that restricts Xarelto to a small part of the market."

Shares in Bayer rose as much as 5.5 percent Friday in reaction to the news, having fallen by as much as 13 percent on September 6 following the publication of the initial FDA staff review.

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