(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 drug, Olumiant, was approved to treat adults with moderate-to-severe active rheumatoid arthritis who have had an inadequate response to commonly-used treatments known as TNF inhibitors.
Analysts have said that a U.S. approval of just the lower dose will limit the business opportunity for Lilly and Incyte. Both the doses of the drug are approved in over 40 countries.
Analysts said the use of the drug in only TNF refractory patients could limit use more than expected.
The decision comes after an independent advisory panel to the agency voted in favor of the lower, 2-milligram dose of Olumiant in April, and against the 4-milligram dose, citing safety concerns.
“The Olumiant approval was a bit worse than the panel’s recommendation,” Morgan Stanley analyst David Risinger said, noting that the vote in favor was for patients who were resistant to methotrexate, another commonly used rheumatoid arthritis treatment.
The drug's label here carries a boxed warning, the strictest form of an FDA warning, and warns of serious infections, malignancies including lymphoma and risk of blood clotting.
Reporting by Manas Mishra and Tamara Mathias in Bengaluru; Editing by Sai Sachin Ravikumar and Shounak Dasgupta