The US Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for Eli Lilly and Incyte’s investigational baricitinib used to treat patients suffering from moderate-to-severe rheumatoid arthritis (RA).
Baricitinib is an oral medication that needs to be administered once daily to the patient suffering from moderate-to-severe RA.
Rheumatoid arthritis is a systemic autoimmune disease that causes inflammation and progressive destruction of the patient’s joints.
Eli Lilly Bio-Medicines senior vice-president and product development and interim president Dr J. Anthony Ware said: “At Lilly, we are committed to improving the lives of people with lifelong chronic diseases such as rheumatoid arthritis, a serious and disabling type of arthritis.
“We will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease.”
While the NDA for baricitinib was submitted to the FDA in January last year, the US agency extended the action date to allow time to review additional data analyses recently submitted by Eli Lilly in response to the agency’s information requests.
The FDA has determined the submission of the additional data in order to constitute a major amendment to the NDA, thereby extending the Prescription Drug User Fee Act (PDUFA) goal date by three months.
The review period delay will not affect Eli Lilly’s previously issued financial guidance for the current year.