- Eli Lilly and Incyte Corp. likely won't resubmit their highly anticipated anti-inflammatory medication for U.S. approval until 2019, according to an update from the companies issued Tuesday.
- The drugmakers explained that another filing for baricitinib as a moderate-to-severe rheumatoid arthritis (RA) treatment won't come in 2017. While discussions with the Food and Drug Administration will help shape the timeline for resubmission, Lilly and Incyte estimate the overall process will take at least another 18 months.
- Baricitinib, an oral Janus kinase (JAK) inhibitor, received approval in Europe and Japan earlier this year for the RA indication. But stateside regulators, after delaying their approval decision three months, delivered a surprise rejection back in April. In a complete response letter, the FDA requested more data on dosing and the drug's safety profile.
Given that it normally takes a New Drug Application approximately 10 months to go from the filing period to an FDA verdict, a minimum 18-month pushback means baricitinib could, at the earliest, break into the U.S. market in late 2019.
But such a timeline — and a potential approval — hinges on Lilly and Incyte's ability to prove their treatment's safety. The FDA wants another clinical trial, but the drugmakers are still evaluating their options.
During a second quarter earnings call on July 25, Lilly CEO David Ricks said his company disagreed with the FDA's rejection, citing the "comprehensive clinical data" that underscores baricitinib's risk-benefit profile. "We do have clarity on the FDA's point of view. It's just not our point of view."
The late-stage program for baricitinib enrolled roughly 3,100 RA patients representing a variety of treatment histories, from naive to refractory.
Key to baricitinib's setback, however, were thromboembolic events, which include deep venous thrombosis (DVT) and pulmonary embolism. Five patients receiving the experimental drug across mid- to late-stage studies experienced the blood clots. While those cases were enough to raise regulator concerns, Lilly BioMedicines' president Christi Shaw said the overall DVT rate of patients treated with baricitinib during late-stage testing was the same as the general background rate for RA.
"That is the rationale for why we disagree with the FDA and why we plan to continue to pursue other opportunities," Shaw said during the July 25 earnings call.
The news pushes Incyte and Lilly further back in the line of drugmakers looking to capitalize on the JAK-inhibitor space. AbbVie, for instance, last month notched strong results in RA patients with its candidate upadacitinib. Pfizer, meanwhile, already has a product on the market in Xeljanz (tofacitinib citrate), another RA medication that brought in $250 million during the first quarter, according to big pharma's most recent 10-Q filing.
Lilly and Incyte are continuing to pursue other indications for their drug, such as atopic dermatitis, lupus and psoriatic arthiritis.
Still, the news puts a damper on the baricitinib's nearer-term prospects. Lilly shares were down 3.6% to $81.69 apiece in late Tuesday morning trading, while Incyte's were down nearly 3% to $134.25 apiece.