Sanofi and Regeneron’s could-be blockbuster Kevzara has been approved by the EMA for rheumatoid arthritis, a month after getting the nod from the US FDA.
An interleukin-6 (IL-6) inhibitor, Kevzara (sarilumab) is the second drug in Sanofi’s emerging immunology franchise after eczema treatment Dupixent (dupilumab), and has been predicted to become a $1bn-plus product by analysts.
The EMA has cleared Kevzara for use in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adults who have responded inadequately to – or who are intolerant to – one or more disease modifying anti-rheumatic drugs (DMARDs).
It will compete in the EU rheumatoid arthritis market with Roche’s $1.7bn IL-6 inhibitor Actemra (tocilizumab), as well as older TNF-blocker drugs including the world’s biggest selling drug – AbbVie’s $16bn Humira (adalimumab). Meanwhile another IL-6 inhibitor from GlaxoSmithKline and Johnson & Johnson – sirukumab – is currently under regulatory review in the US and EU and is also tipped to post $1bn sales at peak.
Sanofi and Regeneron have priced Kevzara at a level that undercuts Actemra and TNF inhibitors in the US and are predicted to adopt a similar tactic in the EU in order to build share for the drug in the crowded rheumatoid arthritis market. In the US its price tag is $39,000 a year, which according to the companies is roughly one-third lower than Humira and other TNF inhibitors such as Amgen’s Enbrel (etanercept). They also have clinical data showing Kevzara was more effective than Humira in a head-to-head assessment.
The new drug will have to contend with cut-price biosimilars of those TNF inhibitors in Europe, however. Just this week Samsung Bioepis joined Amgen with an EU approval for a biosimilar version of Humira, while this morning Novartis’ Sandoz unit confirmed it has been given a green light from the EMA for Erelzi, its version of Enbrel that has also been approved by the FDA. Samsung Bioepis’ Enbrel biosimilar – Benepali – got the go-ahead in the EU in January 2016.
Kevzara will also be promoted for its dosing advantage over Actemra, which is given either by intravenous injection or subcutaneous injection once a week, while sarilumab is dosed every two weeks. GSK and J&J have however suggested that their sirukumab can be dosed just once a month.
That said, patients with rheumatoid arthritis typically have to swap from one treatment to another as the control of symptoms wanes. At the moment, that often means transitioning between TNF inhibitors but the new IL-6 inhibitors may increasingly be used in favour of another drug in the same class, according to some analysts.
“We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics such as TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals,” commented George Yancopoulos, Regeneron’s chief scientific officer.