Xarelto and Tafamidis: Another Case of Less is More

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...