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Lilly claims first place for JAK inhibitor Olumiant in EU

EMA approves once-daily rheumatoid arthritis drug ahead of Pfizer’s Xeljanz
Lilly

Eli Lilly has become the second drugmaker to get a JAK inhibitor approved as a treatment for rheumatoid arthritis (RA), getting the go-ahead in the EU for its Olumiant drug.

It reaches the global RA market in second place behind Pfizer's Xeljanz/Jakvinus (tofacitinib), but is the first JAK inhibitor to be approved in the EU for this indication and according to analysts could become a $2.4bn brand for Lilly by 2022.

The EMA has approved once-daily Olumiant (baricitinib) for the treatment of moderate-to-severe active RA in adults who do not respond to or cannot tolerate older disease-modifying anti-rheumatic drugs (DMARDs). It can be used as monotherapy or in combination with the widely-used DMARD methotrexate.

Xeljanz was approved for RA by the US FDA in 2012 and brought in $927m in revenues last year, up 77% on 2015. Just $19m of that total came from European markets, however, as Pfizer's drug has been held up by regulatory setbacks in the EU bloc, although it was re-submitted for approval last year. The original formulation of Xeljanz was dosed twice-a-day but a new once-daily version called Xeljanz XR was cleared by the FDA last March.

Another JAK inhibitor - Novartis' Jakavi/Jakafi (ruxolitinib) - is also on the market but is indicated for haematological cancers.

Olumiant has been given a green light on the back of studies showing it is more effective than methotrexate and AbbVie's injectable TNF inhibitor Humira (adalimumab) - currently the biggest-selling drug in the world - at alleviating symptoms in RA patients.

A verdict on Lilly's new drug is expected in the US in April after an earlier review deadline was pushed back by three months.

It is expected to put in a strong showing as it pursues Xeljanz in the RA market, in part because lingering safety concerns have meant Xeljanz is typically reserved as a later-line therapy after biologics such as Humira in the US. As Olumiant has outperformed Humira in a comparative trial, it could eventually be used as a first-line agent in methotrexate-refractory RA patients, according to analysts.

"Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability," said Anthony Ware, senior vice president for product development and interim president at Lilly Bio-Medicines.

"We believe that as a next-generation therapy in the EU, baricitinib will advance RA treatment by helping adults with active moderate to severe RA who have inadequately responded, or are intolerant, to DMARDs feel better quickly."

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

15th February 2017

From: Regulatory

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