Despite a 15-2 vote by an advisory panel in favor of the experimental anticlotting drug rivaroxaban, the FDA isn’t approving the drug at this point. Johnson & Johnson, which would market the drug in the U.S., said it got a “complete response” letter from the FDA — in other words, a non-approval. Bayer sells the drug in Europe under the brand name Xarelto. J&J has been seeking approval for use of the drug to reduce the risk of blood clots in the weeks following knee- and hip-replacement surgeries. J&J didn’t provide many details on the FDA’s letter, but said it’s evaluating the letter and will respond to the agency’s questions ASAP. The company noted that the agency hasn’t requested that new studies be conducted on the drug’s safety and efficacy before approval for this use, and added that J&J is “confident in the positive benefit-risk profile of rivaroxaban.” In a note to investors,

Cowen & Co. analyst Sara Michelmore wrote that “lingering concerns” about a risk of harm to the liver likely prompted the FDA to take more time to review data from a recently completed study called Atlas. She now expects approval late this year but adds there could be more delays if the FDA wants safety data from ongoing studies that test higher doses of the drug for longer periods of time. The FDA usually follows advisory panels’ advice, but lately it has certainly been willing to go in a different direction. For instance, last year the agency rejected Schering-Plough’s sugammadex for surgical patients despite a unanimous recommendation from a panel. It also went against panels’ advice on J&J’s intravenous antibiotic Doribax and its psoriasis medicine, ustekinumab. Image of red blood cells by Janice Haney Carr via CDC

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FDA Isn’t Ready to Approve J&J Anticlotting Drug