Drug Development, FDA

Restructuring the pipeline, Eli Lilly says a baricitinib comeback in rheumatoid arthritis could take years

Eli Lilly was supposed to mark this year with the launch of a new blockbuster medicine for rheumatoid arthritis — waging a commercial war with some high-profile rivals. Instead, it is now facing a years-long delay in order to mount a new study aimed at resolving the FDA’s safety fears for baricitinib. And its rivals are gaining a big head start in a major market.

In the meantime, Lilly’s Q2 report includes the news that the pharma giant is reorganizing its pipeline, prioritizing 10 drugs in the oncology portfolio while planning to outlicense the rest of the slate.

Lilly $LLY had been close-mouthed about the reasons for the stunning rejection of baricitinib in April. But in a new statement out early Tuesday, the pharma giant made it clear that regulators had pulled the plug on baricitinib after fretting about a series of thromboembolic events — blood clots diagnosed as deep venous thrombosis and pulmonary embolism — in two of seven Phase II and Phase III studies.

Running a new trial to get the FDA the new data regulators are demanding and resubmitting the application will take at least 18 months, says Lilly, which is one of the slower drug developers among the largest pharmas in the industry. Drug reviews also typically take 10 months to complete. And some analysts, like Leerink’s Seamus Fernandez, are shoving this one down the line by four long years.

Notes Fernandez: “While these updates are disappointing, it is consistent with our modeled US introduction in 2021.”

Investors didn’t like the news. Lilly’s shares dropped close to 3% while its partner Incyte saw its price slide 2.5%.

Lilly, meanwhile, appears ready to make some big changes in the cancer drug pipeline it’s been building. From its Q2 release:

Using this framework, Lilly will now focus on seven pipeline assets for priority internal development and three additional assets which are pending data from ongoing trials. The company has or will seek external partners on the other molecules in clinical development as appropriate.

On the table for acquirers are these 6 Phase II programs:

  • Galunisertib, a TGF-b inhibitor in Phase II for hepatocellular carcinoma.
  • Ralimetinib, a p38 mitogen-activated protein kinase inhibitor in Phase II for ovarian cancer.
  • Emibetuzumab, a MET antibody in Phase II for non-small cell lung cancer.
  • A notch inhibitor
  • An FGFR inhibitor
  • A CXCR4 peptide inhibitor

Lilly execs are clearly not happy about the baricitinib setback.


“We disagree with the FDA’s conclusions, and believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib’s approval as a new treatment option for people suffering from RA in the United States,” said Christi Shaw, president of Lilly Bio-Medicines. Yes, the company, admitted, there was an imbalance in events if you look at the controlled studies that compared the drug with a placebo. But if you step back the rate was the same over the course of the full development program.

European and Japanese regulators, Lilly argues, were willing to deal with the data by adding a note of caution warning patients at risk for DVT and PE.

Clearly, the FDA isn’t accepting that argument.

In the meantime, Regeneron and Sanofi have strutted ahead to win a delayed OK on sarilumab while AbbVie works on its own successor to Humira, ABT-494. And Gilead is moving confidently ahead with a massive Phase III program for filgotinib.

All of these drugs have been tapped as new therapies that could earn anywhere from $2 billion to $3 billion each. This is not a race that Lilly could afford to lose.


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RAPS Regulatory Convergence 2017