Lilly Reels After FDA Rejection, But 'Development Drought' Unlikely

Apr 17, 2017

Credit Eli Lilly / https://www.lilly.com/newsroom

Indianapolis-based Eli Lilly has been dealt another blow by the U.S. Food and Drug Administration, which failed to approve a newly-developed treatment for rheumatoid arthritis.

In what is referred to as a “complete response letter,” The FDA stated it wants Lilly to supply more data to clarify safes dosage levels and put certain safety concerns to rest.

The news caused Lilly stock to fall 4 percent Monday – though that’s not as steep as after the company’s announcement late last year that a much-anticipated Alzheimer’s drug had failed a late-stage clinical trial.

The FDA rejection of Lilly’s baricitinib prompted some to wonder when, exactly, Lilly would finally get another new drug to market. According to FDA records, the agency only approved a couple new drug applications, or NDAs, from the company from 2013 through 2016.

(That doesn’t include FDA approval of biologics license applications, which cover therapedic products usually derived from living tissue, such as Lilly’s psoriasis drug Taltz. The FDA approved four such applications in the same time period.)

Northwestern University healthcare economist Dustin French waves away such concerns. He says he expects the arthritis drug to be approved eventually, especially because it’s already been cleared for use in Europe.

French says he expects eventual approval of the baricitinib in the U.S.—and for it to potentially make the company a lot of money.

I think what they do is they’re looking at a condition that is fairly common,” he says. “You don’t want to treat a super super rare condition and the market penetration—people that actually need the drug—is small.”

French says even though Lilly’s development schedule isn’t exactly speedy, the company benefits from a diverse drug portfolio.

“They spend years developing… and out of all the things they test, they might be lucky to get one or two on the market,” says French. “Lilly though looks different from a lot of other pharmaceutical companies in that they’re not a one-trick pony they have multiple drugs out there.”

An Eli Lilly spokeswoman declined to comment on the arthritis drug setback, citing ongoing discussions with the FDA. In a news release, the company says it disagrees with the agency’s conclusions.

“The companies disagree with the Agency's conclusions,” the press release says, referring to Lilly and Incyte Corp, its development collaborator. “The timing of a resubmission will be based on further discussions with the FDA.”

FDA approvals for new drugs dipped significantly last year, with only 22 novel (brand-new) drugs approved.