Roxadustat Rejection Has Lessons For Other Sponsors

 
• By Michael McCaughan

A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.

Modeling clay monster (Alamy)
This modeling clay figure may not get a warm reception. The modeling studies suggested by sponsors could also provoke negative reactions at advisory committees. • Source: Alamy

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