Sanofi, Regeneron aim to undercut rivals with new RA drug

The FDA has approved Sanofi and Regeneron's rheumatoid arthritis drug, Kevzara (sarilumab), at the second time of asking after the companies fixed manufacturing issues that prompted a rejection last autumn.

The regulator had no concerns about the efficacy and safety of Kevzara, so it always looked like approval was on the cards once the FDA approved the plan to address the manufacturing concerns raised last November.

Kevzara is in a group of new rheumatoid arthritis medicines that are intended as successors to established drugs such as AbbVie's Humira (adalimumab) and Johnson & Johnson's Remicade (infliximab) anti-TNFs, which have been on the market for many years.

There is also a cheaper biosimilar of Remicade on the US market, which could compete with branded rivals because of its price tag.

Kevzara, an injected interleukin-6 receptor antibody, will be priced at $39,000 a year, a discount of almost a third compared with rivals.

Sales are expected to peak at around a billion dollars, which, along with up to $4 billion a year from eczema drug Dupixent, will ensure the cash keeps flowing for Sanofi as its big-selling insulin injection Lantus faces biosimilar competition.

With the approval of Dupixent in the US, and Kevzara's approval in Europe, Sanofi has suddenly put together an immunology franchise that could generate some much-needed sales as its older drug struggles.

Kevzara's biggest issue is the competitive nature of the RA market.

Roche has already got an IL-6 drug on the market with its Actemra and, aside from other established drugs, sarilumab will probably have to contend with sirukumab, a rival IL-6 drug from Johnson & Johnson and GlaxoSmithKline.

The FDA is due to make a decision on sirukumab in the third quarter.

In Sanofi's favour is the FDA's shock rejection of Eli Lilly's baricitinib last month, because of safety concerns, which had been predicted to generate more than $2 billion in peak sales thanks to its patient-friendly pill formulation.

Despite the competition, it's worth Sanofi's while bringing the drug to market because rheumatoid arthritis patients often switch from one drug to another through their lifetimes.

The FDA approved Kevzara in adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs, such as methotrexate.

Sanofi's CEO, Olivier Brandicourt, said: “Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options.”