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Sanofi/Regeneron's Sarilumab cleared by FDA on second attempt

IL-6 inhibitor to treat adult RA patients


Sanofi and Regeneron's would-be blockbuster sarilumab has been approved by the FDA for rheumatoid arthritis after being turned down by the agency last year.

The interleukin-6 (IL-6) inhibitor has been immediately launched under the Kevzara brand name as a treatment for adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate.

It is the second IL-6 inhibitor to reach the US market after Roche's Actemra (tocilizumab), which made its debut in 2010 and is a big earner for the Swiss drugmaker with sales of around $1.7bn last year, claiming the runner-up slot ahead of rival sirukumab from GlaxoSmithKline and Johnson & Johnson (J&J), which was filed in the US last September.

Kevzara has a dosing advantage over Roche's drug, which is given either by intravenous injection or subcutaneous injection once a week, while sarilumab is dosed every two weeks. Sirukumab meanwhile can be given once a month, according to its developers.

Sanofi and Regeneron are also banking on competitive pricing to make headway in the market, where the new agent will also have to take on established TNF inhibitors as well as new and cheaper TNF biosimilars. They are setting the price of Kevzara at $39,000 a year, which they say is a discount of around a third on the two most widely-prescribed TNF blockers, AbbVie's Humira (adalimumab) and Amgen's Enbrel (etenercept).

A recent report from the Institute for Clinical and Economic Review (ICER) in the US suggested that the leading TNF blockers for RA had seen price rises in recent years that have taken them above the threshold for cost-effectiveness. It suggested ‘regulatory intervention’ may be needed to stop future price rises. Kevzara's lower price suggests market forces may also come into play.

Kevzara was approved in Canada earlier this year, and also got a recommendation for approval from the EMA's Committee for Medicinal Products for Human Use (CHMP) last month.

There was also good news for Roche this week after the FDA gave a green light to Actemra as a therapy for patients with giant cell arteritis (GCA) - its sixth indication - becoming the first approved drug for the severe autoimmune disease in the US.

GCA causes severe headaches, jaw pain and visual disturbances and - if left untreated - can lead to blindness, aortic aneurysm or stroke.

Article by
Phil Taylor

23rd May 2017

From: Regulatory



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