FDA Panel After Once more Rejects New Indication For J&J Drug

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee once once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). The virtually unanimous vote (10-, with one abstention) was in line with a hugely adverse overview from FDA workers members.

Although originally the topic of higher praise when it initial came out, the pivotal ATLAS ACS two-TIMI 51 trial has been bedeviled by criticism because the FDA drew consideration to the unusually massive sum of missing trial information. Previous discussions of the trial at the FDA brought the word “missingness” into widespread utilization in the health-related local community. Although J&ampJ made efforts to supply some of the missing data this time around, in the end the panel members agreed with the most latest assessment from the FDA reviewers that the huge quantity of still-missing data made it unattainable to reach firm conclusions about the relative security and efficacy of the drug in the setting of ACS.

Panel member Linda Fried, from the University of Pittsburgh, gave voice to a view adopted by many of the committee members. ATLAS, she mentioned, was most likely “an all round optimistic study” but, since of the big sum of missing information and the absence of a confirmatory research, was “not robust enough” to support the ACS indication. Speaking on behalf of the sponsor, cardiologists C. Michael Gibson and Marvin Konstam attempted to persuade the panel to accept their numerous constructive analyses of the trial. But panel members, such as outspoken critics like Steve Nissen and Sanjay Kaul, left small doubt all through the day’s meeting that they have been unlikely to vote in favor of the new indication.

“We enjoy the thoroughness of the committee’s evaluation and proceed to feel rivaroxaban, in addition to the recent normal of care, might aid provide sufferers with ACS further safety against lifestyle-threatening cardiovascular occasions this kind of as death, heart assault and stroke. We will operate with the FDA to tackle questions raised nowadays,” mentioned J&ampJ’s Paul Burton, in a statement.

FDA Panel After Once more Rejects New Indication For J&J Drug