FDA

In stunning about-face, FDA invites Eli Lilly to quickly refile blockbuster hopeful baricitinib

Just a few weeks ago Eli Lilly $LLY made it clear that the FDA was demanding a new clinical study to clarify the safety profile of its would-be rheumatoid arthritis blockbuster baricitinib, delaying any resubmission by at least 18 months and perhaps years.

But this morning the pharma giant and its biotech partners at Incyte $INCY say they’re filing a new marketing pitch in just 5 months in an attempt to bull their way to an approval by mid-year.

In a statement to Endoints News, Lilly says the FDA invited a new application without the requirement to complete a new study, marking a potentially dramatic change in its stance.

The FDA has granted us the opportunity to file our resubmission package without a new clinical study.

That’s no guarantee of a quick approval, but it reflects a major shift in the FDA’s stance on an important new drug, one that comes after President Donald Trump appointed Scott Gottlieb to run the FDA.

Lilly shares surged 2.4% on the news, with Incyte spiking 4%.

The FDA declined to comment, a standard practice at the agency, which lets the companies do all the talking.

Lilly took months to explain the FDA’s reason for the stunning rejection, recently noting that regulators concerns about thromboembolic events –clotting — in two of 7 studies raised an alarm, even though Lilly completely disagreed with the agency’s position on safety while insisting that there was nothing aberrant about the rate of clots. Lilly noted in a statement this morning:

Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data. The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle.

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 U.S.”

Gottlieb won lawmakers’ support for his appointment a few weeks after Lilly was handed a rejection in April. While he vowed to maintain the gold standard on safety and efficacy, Gottlieb also pledged to do everything possible to accelerate new drug OKs, urging that all of the agency groups follow the path pursued by its aggressive oncology division.

If the agency follows through with an approval soon, the implications would be profound for everyone in drug development, particularly the larger players like Lilly.


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