The FDA issued a narrower approval than expected for the Eli Lilly and Incyte rheumatoid arthritis drug Olumiant (baricitinib).
The drug was initially seen as a potential blockbuster with projected peak sales of $2 billion. Last year, however, the FDA rejected it, citing concerns about rates of infection, clotting and cancerous growths.
The agency approved a lower, less effective dosage of the drug, which will carry a black-box warning about potential safety hazards. The drug’s indication will also be restricted to patients whose rheumatoid arthritis has remained after treatment with immunosuppressants.