GSK, Janssen submit sirukumab in Europe, planning for 2016 FDA filing

GlaxoSmithKline ($GSK) and partner Johnson & Johnson ($JNJ) have submitted their next-gen IL-6 arthritis med sirukumab to the EMA a month before rivals Regeneron ($RGEN) and Sanofi’s ($SNY) offering sarilumab will see an FDA decision on its approval.

Specifically, the two U.K.-U.S. partners have submitted their marketing app to European regulators for a subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for patients with moderately to severely active rheumatoid arthritis (RA).

The license both are initially seeking will see the mAb teamed up with methotrexate in RA patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs, as well as being used on its own in patients who can’t use methotrexate.

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Back in June, the two released positive Phase III data for their experimental med showing it hit its co-primary endpoints of having less joint damage after one year compared to placebo, and it improved patients’ condition by 20% or more in half of those in the treatment arms under the ACR20 score.

GSK and J&J’s biologics arm are in a race with Sanofi and Regeneron to carve out market share in a saturated market, although their rivals will likely beat them to market in both the U.S. and Europe.

Their med, sarilumab, is already in front of the FDA, which has a PDUFA date set for the end of October. Sarilumab has in testing bested AbbVie’s megablockbuster ($ABBV) Humira (adalimumab) in a Phase III trial. The treatment has long been pegged as a blockbuster in waiting, with 2020 sales predicted to hit $1.8 billion, according to analyst estimates compiled by EvaluatePharma.

Meanwhile, Sanofi/Regeneron are eyeing a 2017 EU approval for their med after the EMA accepted its review at the start of August. GSK and J&J said that a U.S. submission for their drug is “planned for 2016,” although no timelines were given.

If approved, both drugs will face competition from incumbents including Humira, an incoming wave of biosimilars and, potentially in the future, JAK1 inhibitors and other next-generation products from the likes of AbbVie and Gilead ($GILD).

Paul-Peter Tak, GSK’s chief immunology officer and SVP of its R&D pipeline, said: “We have worked with our partner Janssen to develop a robust regulatory package to support the use of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis. We believe sirukumab, if approved, will provide these patients with a once every four week subcutaneous treatment option.”

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