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Xarelto and Tafamidis: Another Case of Less is More

 
• By Michael McCaughan

A pair of advisory committee reviews at the start of June offered an interesting contrast: a big study with small flaws versus a small study with big flaws. At least at the committee level, the small study fared much better. Is this another vote against mega R&D investments?

FDA convened two very interesting advisory committee reviews during the first week of June. On the surface, the applications look like polar opposites. One was for a new indication for an already marketed anti-clotting drug: Johnson & Johnson/Bayer AG’s Xarelto (rivaroxaban) for use in acute coronary syndrome. The other was for an “ultra-orphan” neurological indication: Pfizer Inc.’s tafamidis for treatment of familial amyloid polyneuropathy.

The differences go beyond the target disease: these two applications present a stark contrast in scale. One statistic captures the difference: the pivotal study of Xarelto for ACS enrolled significantly...

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