FDA Rejects Eli Lilly’s Blockbuster Contender Baricitinib

The FDA has rejected Eli Lilly’s (NYSE:LLY) blockbuster contender baricitinib, saying that the pharma giant will need to gather more data to determine the proper doses that should be used by patients before regulators can reconsider their decision.

Written by John Carroll (ENDpts.com)

The kickback marks a stunning setback for…CEO Dave Ricks, who owes investors a string of promised approvals following a long drought in the clinic. The pharma giant is known for its careful, if slow, approach to late-stage development. Baricitinib has been tagged as one of the top blockbusters in late-stage development. The rejection is also a setback for its biotech partner, Incyte Corp. (NASDAQ:INCY), which licensed out the drug to Lilly.

Both of these companies face a drubbing on Wall Street, but Lilly chose to release the news on the morning of Good Friday, a bank holiday.

The rejection provides Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and its partners at Sanofi SA (NYSE:SNY) a chance to overcome its rejection on sarilumab — for manufacturing reasons — and push ahead with a rival therapy that many analysts believe is the odds-on favorite. It also marks another advantage for AbbVie Inc. (NYSE:ABBV), which has been circling the wagons around Humira as it mounts a defense against new therapies biting off pieces of its multibillion dollar franchise therapy.

Said Christi Shaw, president of Lilly Bio-Medicines:

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA. We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”