Lilly gets second shot at application for ‘blockbuster’ arthritis drug

Earlier this year, Eli Lilly was on the receiving end of one of the most surprising setbacks in recent times for its rheumatoid arthritis drug, baricitinib. The FDA rejected the drug and asked Lilly for more data, after it pointed out instances of blood clotting in trial data.

Lilly was adamant that this was not an issue, citing that this was common in such patients and not a cause for concern. It appears that the FDA may have had a rethink and accepted this argument, after Lilly announced that it would be able to resubmit for marketing authorisation before the end of January 2018.

This is a considerable boon to Lilly, as it could potentially have fallen behind other companies looking to push their own JAK inhibitors to market. The potential to have its new NDA reviewed and, potentially, approved by mid-2018 would see it be able to cement its position in the market before its rivals, Gilead and AbbVie.

Ahead of the pack, Pfizer already has its own JAK inhibitor on the market, with Xeljanz, but there has been to suggest that the higher dose of baricitinib, at 4mg, could hold advantages over this treatment. Sales of Xeljanz are looking strong for Pfizer, with Q2 figures beating estimates by reaching $336 million. If baricitinib can take a considerable chunk of the market, it will be looking at blockbuster sales.

"We are committed to making life better for people living with RA. There is a significant unmet need for Americans suffering from this debilitating disease in spite of available therapies," said Christi Shaw, President of Lilly Bio-Medicines. "We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the US."

Baricitinib has already been approved for use in Europe and Japan, under the brand name Olumiant. The approvals in these regions are part of the reason why the FDA’s rejection of the initial NDA came as such as a surprise to observers.