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Lilly nears EU approval of arthritis drug baricitinib

On course for early 2017 verdict, setting up challenge to Pfizer’s Xeljanz
Eli Lilly

Eli Lilly has secured CHMP backing for key pipeline prospect baricitinib for rheumatoid arthritis (RA), setting it on course for approval in early 2017.

The EMA's committee gave a positive opinion on baricitinib - in the same class as Pfizer's Xeljanz (tofacitinib), which is currently the only JAK inhibitor used in RA - for patients who have not responded adequately to or cannot tolerate one or more disease-modifying anti-rheumatic drugs (DMARDs).

Baricitinib - which will be sold as Olumiant - has been approved on the back of clinical trials showing it was more effective than RA staple drug methotrexate and AbbVie's injectable TNF inhibitor Humira (adalimumab) in alleviating symptoms in RA patients.

The CHMP approval bodes well for a positive verdict by the US FDA, which is due to complete its review of the drug next month, and sets Lilly on its pursuit of Xeljanz, which brought in sales of $649m for Pfizer in the first nine months of 2016, an 85% increase on the prior year but still well short of analysts' initial expectations.

Xeljanz has been held back by a failure to get approval for RA in Europe - although it refiled earlier this year - and lingering safety concerns among physicians in the US, which has meant it is often only used in patients who have failed multiple biologic therapies, according to Datamonitor.

Analysts at Credit Suisse suggest that thanks to a more favourable clinical profile compared to Xeljanz baricitinib could grow into a $2.4bn product in 2020, with additional sales possible from indications in cancer. In particular, besting Humira in a comparative trial means it could be used as a first-line agent in methotrexate-refractory RA patients.

The CHMP positive opinion is also a boost for Incyte, which originally developed the drug and stands to receive a $65m milestone on EMA approval along with royalties on sales.

Meanwhile, other JAK inhibitors in late-stage development for RA that could reach the market in the next couple of years include Galapagos/Gilead Sciences' filgotinib, AbbVie's ABT-494 and Astellas' peficitinib.

Article by
Phil Taylor

19th December 2016

From: Regulatory

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