Regeneron, Sanofi win a delayed OK for rheumatoid arthritis IL-6 heavyweight sarilumab
It took more than six months and likely caused more than a few red faces, but Sanofi has dealt with the FDA’s issues with its manufacturing ops and won a green light to start marketing the likely blockbuster sarilumab alongside its partners at Regeneron.
Consensus peak sales forecasts on the drug — to be marketed as Kevzara — top the $1 billion blockbuster mark, making it a big addition for both companies.
The partners say they set the WAC at $39,000/year for the 200 mg and 150 mg doses, which is approximately “30 percent lower than the WAC for the two most widely used TNF-alpha inhibitors.” Those two are Humira – which earned $16 billion last year – and Enbrel.
The IL-6 drug whetted analysts’ expectations last March when it beat out AbbVie’s Humira in a head-to-head showdown for rheumatoid arthritis. The Humira data weren’t in regulators’ package for the approval, but you can be sure that payers will give it a good look over once the sales team hits the streets. On the downside, sarilumab was linked to a significantly higher rate of neutropenia.
Leerink highlighted the price competition with a nod to the lower price model.
As importantly, Kevzara is also approximately 15% below the price of Actemra at the highest dose and, with discounts, should offer a cost effective treatment option for payers in this setting. In a recent Institute for Clinical and Economic Review (ICER) analysis, Kevzara did not reach a typical $100,000 per quality-adjusted life year (QALY) cost effectiveness threshold at this level, but neither did any of the other widely prescribed biologicals for this disease, including Enbrel, Humira, Cimzia, Orencia, Actemra and Xeljanz.
Sarilumab now becomes the third antibody to win approval from a Regeneron/Sanofi partnership. The first was the PCSK9 drug Praluent, which has triggered a bruising legal battle with Amgen and has yet to find any real traction in the market, despite its dramatic impact on cholesterol. The partners are now lining up cardio outcomes data from a big Phase III, hoping to push that out front of the competition. Then there was an OK earlier this year for Dupixent, which a number of forecasts have pegged as a potential megablockbuster.
Rheumatoid arthritis is a tough disease to beat, especially when you have to line up against some big rivals that are already well entrenched in the field. J&J and GlaxoSmithKline demonstrated that when they came up with mixed results in their head-to-head with sirukumab vs. Humira. But it was Eli Lilly that turned in the big nasty surprise, with the FDA stunning analysts with their rejection of baricitinib, a drug licensed from Incyte.
“In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms and improving physical function, resulting in significantly less radiographic progression of structural damage of RA,” said Alan Kivitz, an investigator in the global SARIL-RA clinical program for sarilumab. “This is important because not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”