EMA recommends approval for baricitinib

Eli Lilly and Co., along with Incyte Corp., have announced that baricitinib received a positive opinion as well as a recommendation for approval from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CMPHU).
If baricitinib is approved, it would be marketed and distributed under the name OlumiantA.
Baricitinib was developed to treat moderate-to-severe active rheumatoid arthritis in adult patients who have had adverse responses or are intolerant to one or more disease modifying anti rheumatic drugs.
"Rheumatoid arthritis is a debilitating disease and can have a devastating impact on a person's quality of life," Lilly President of European and Canadian Operations Andrew Hotchkiss said. "There is no cure for rheumatoid arthritis (R.A.) and although improvements have been seen in the long term outcomes for patients, not all people reach low disease activity or remission. Baricitinib is the first JAK inhibitor to receive a positive CMPHU opinion for the treatment of R.A. in the E.U. It is an important milestone for people living with rheumatoid arthritis and Lilly is committed to improving outcomes for people living with this chronic condition."
Baricitinib can be used by itself to treat R.A. or as a combination with methotrexate.