Baricitinib re-submission within five months

30 August 2017

A potential rheumatoid arthritis (RA) blockbuster could yet be available in the USA within the next year after its manufacturers were given the go-ahead to complete a re-submission package without the need for a new clinical study.

The news led shares in both pharma major Eli Lilly (NYSE: LLY) and its biotech partner Incyte Corporation (Nasdaq: INCY) to open up by single-digit percentages in Wednesday’s trading.

The US companies announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases in 2009, and in 2016 they made submissions for marketing approval for its use as a treatment of RA in the USA, the European Union (EU) and Japan.

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