With competition lurking, Eli Lilly's baricitinib must show unparalled efficacy

Investigative RA agent baricitinib must hit the ground running with an unparalleled efficacy profile in order to grab the spotlight in its drug class. But AbbVie's Humira and other anti-TNF biologics will likely remain on their mega-blockbuster shelf just out of the oral JAK inhibitor's reach.

The Janus kinases — a group of tyrosine kinases that include JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2) — play an important role in immune defense. Baricitinib, a JAK inhibitor licensed to Eli Lilly by Incyte, is set for success. The agent met its primary endpoints in four global Phase III studies and proved superior to Humira on two common clinical measures of RA, meeting the study's secondary goals.

“Baricitinib's safety and efficacy profiles are excellent,” says Dr. John Bradley, senior medical fellow of U.S. medical affairs at Lilly. If cleared by the FDA, Lilly expects to launch baricitinib early in 2017.

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Competition for baricitinib exists: Pfizer's Xeljanz (tofacitinib), the first oral disease-modifying antirheumatic drug (DMARD) in a decade. Big-name injectable TNF inhibitors like Humira (adalimumab), Amgen/Pfizer's Enbrel (etanercept), and J&J's Remicade (infliximab) command the RA market, to the tune of billions of dollars annually.

Xeljanz cleared the way for a new treatment paradigm. Digitas Health LifeBrands' VP, group director, science and medicine Lee Fraser, PhD, believes the uptake of Xeljanz (and its inclusion in guidelines) will be a good analog for the developers of baricitinib to follow, adding that the key will be to differentiate itself from the first arriver.

The bar for market success has been set high for baricitinib. Riding on a successful clinical profile, baricitinib's arrival could be well timed, given that Xeljanz is still searching for its market magic. “If the injectable market is to be replaced by a pill, baricitinib is the likely front-runner,” says Gil Bashe, managing partner, Finn Partners.

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But that's a big if. Any competitive edge gained in the JAK inhibitor class is not expected to transcend the sector, as it's unlikely any of these agents will unseat first-line biologic gold standards like Enbrel.

For most of its development life, baricitinib has generated excitement about its dosing profile. That said, it still may not be able to play the once-daily card as much these days. In late February, FDA approved an extended-release version of Xeljanz, making it the first once-daily oral JAK inhibitor for RA.

“Pill power is not enough, even in the face-off against injectables,” Bashe notes. “If payers are excited by the comparative data and the price is right, Lilly/Incyte will have a blockbuster.”

The drug pipeline is cultivating additional competitors — among them Gilead/Galapagos' filgotinib, a highly selective JAK 1 inhibitor. “Early data indicate that it will not be quite as potent as Xeljanz or baricitinib,” says Mark Finn, VP and account director at AbelsonTaylor.


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