Drug Development

We don’t know when (exactly) Lilly will announce the FDA’s baricitinib decision, but watch out for the looming pricing squabble

Sometime in the next few days, the FDA will be right on the PDUFA decision deadline for baricitinib. We just don’t know which day.

For some reason, Eli Lilly $LLY has decided to keep the deadline under wraps, as confirmed yesterday by a spokesperson for the company. It could be tonight, ahead of a long holiday weekend in the US. It could be tomorrow. They could even wait until Monday, after the decision is formal, to roll out their announcement.

While delayed from three months ago to some time in mid-April, just about every analyst believes that — barring some sort of manufacturing issue or some other unexpected snafu — Lilly and its biotech partner Incyte $INCY have this one in the bag. And it’s another whopper.

After being treated to a string of blockbuster OKs for Ocrevus and Dupixent, baricitinib — which will be marketed as Olumiant — is looking to disrupt the rheumatoid arthritis market. To do that, Lilly has carefully managed a drug that analysts believe could earn up to about $2 billion in peak sales.

Lilly is well known in the industry for its appetite for huge studies and pricey comparisons with the competition. In this case, it paid off with new data that demonstrated superiority over Humira in treating rheumatoid arthritis. Humira is still under patent protection, and will remain so for as long as AbbVie can fight off generic competition to the biggest revenue producer in the company and one of the biggest drugs on the planet.

So the next big thing, if indeed the FDA has given baricitinib the green light, will be the price.

A new report from ICER took issue with the price for Humira, which it posted as a net of $40,415 a year. And ICER provided a thumbs up for baricitinib and sarilumab, another drug from Regeneron and Sanofi that got held up by one of those manufacturing snafus. ICER clearly prefers sarilumab on efficacy, though we don’t know the price, giving its marginal stamp of approval to baricitinib.

Not surprisingly, AbbVie took exception to the report, and Lilly may well end up doing the same. In this brave new world, an FDA approval is a prelude to the price debate. And this one should be a doozie.


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