- Eli Lilly and Incyte hit a setback in the Food and Drug Administration's review of their much-anticipated rheumatoid arthritis drug baricitinib, announcing last week the regulator had delayed its target action date for the drug by three months.
- Submitted for approval in January 2016, baricitinib is a once-daily oral JAK1/2 inhibitor which the companies hope can make inroads in a crowded market. A delay stings, but the FDA did not ask for additional studies, which would have more significantly hurt the companies.
- A decision is now expected in the spring. Jefferies predicts sales of $17 million for 2017, climbing to $760 million by 2025, which could account for almost 15% of Incyte's potential revenues.
With baricitinib, Lilly and Incyte will be pushing into a crowded rheumatoid arthritis market dominated by blockbuster biologics.
Yet baricitinib could find a niche among patients who don't fully respond to existing drugs. Long-term data for baricitinib showed clinically meaningful improvements, including in pain, fatigue, physical function and physical health-related quality of life, in both previously untreated patients and those who had failed a number of other drugs. Baricitinib has also demonstrated better results in some areas than AbbVie's top-selling Humira (adalimumab).
Lilly and Incyte can draw comfort from the fact that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for baricitinib back in December 2016. This step, analysts at Jefferies suggest, means that "there is likely nothing detrimental underlying that would significantly derail the program."
According to the drugmakers, the FDA extended its review in order to take "additional data analyses" submitted by Lilly into consideration. No further specificity was given, but the action could reflect an effort to win a stronger label for the drug, Jefferies analysts said.
Incyte has seen its shares climb in value recently, as news that a combination treatment pairing its experimental drug epacadostat and Merck's Keytruda (pembrolizumab) had moved into Phase 3 trials generated some buzz at the J.P. Morgan Healthcare Conference last week.