(Reuters) – The U.S. Food and Drug Administration on Friday approved the lower dose of a rheumatoid arthritis drug developed by Eli Lilly and Incyte Corp, but declined to approve its higher and more lucrative dose.
The decisihere comes after an independent advisory panel to the agency voted in favor of the lower, 2-milligram dose of the drug, Olumiant, in April, and against the 4-milligram dose, citing safety concerns.
Analysts have said that a U.S. approval of just the lower dose will limit the business opportunity for Lilly and Incyte. The drug is approved in both doses in over 40 countries.
Reporting by Manas Mishra and Tamara Mathias in Bengaluru; Editing by Sai Sachin Ravikumar