Sanofi and partner Regeneron are facing a delay in their bid to bring rheumatoid arthritis drug sarilumab to market, after the FDA turned down their marketing application.
The agency’s complete response letter (CRL) said it was unable to approve the interleukin-6 (IL-6) inhibitor because of “deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility where sarilumab is filled and finished”.
Sarilumab is a key pipeline drug for both Sanofi and Regeneron, and has been predicted to become a blockbuster after beating AbbVie’s Humira (adalimumab) – the biggest-selling drug in the world – in a head-to-head trial. Analysts have previously predicted the drug could bring in more than $1bn by 2020.
Sanofi says it has submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions at the plant.
Any delay to the programme is however a blow to Sanofi and Regeneron, which are playing catch-up against the only marketed IL-6 inhibitor – Roche’s Actemra/RoActemra (tocilizumab) – while also trying to stay ahead of rivals with IL-6 inhibitors in late-stage development.
Actemra continues to deliver strong growth for Roche – bringing in $1.25bn in the first nine months of 2016, a rise of 17% driven by the adoption of a new subcutaneous formulation. GlaxoSmithKline (GSK) and Janssen are in pursuit of the market as well, with their sirukumab drug already filed in the US and Europe.
Sanofi chief executive Olivier Brandicourt told investors on Friday – ahead of the FDA’s letter – that the manufacturing deficiencies are not specifically related to sarilumab but are not expected to affect the supply of “currently marketed products or other products that are under regulatory review”.
That includes an even bigger pipeline line drug, dupilumab for atopic dermatitis, which has been tipped to become a $2.8bn brand if approved and is also finished at Le Trait.
“We expect this matter to be resolved before the expected 29 March PDUFA date [for dupilumab],” said Brandicourt. “In addition, we have redundant capabilities if necessary,” he added.
News of the delay put a damper on Sanofi’s third-quarter results, which were better than consensus forecasts thanks to a strong showing from rare disease unit Genzyme and its vaccines business.
Group revenues rose 2% to €9.65bn, despite the effect of biosimilar competition in the US to Sanofi’s big-selling Lantus (insulin glargine) product for diabetes, which slipped 10% to €1.39bn in the quarter.
The company announced plans to sell its European generics business within the next two years, and said its ongoing cost reduction drive should result in at least €1.5bn in savings by 2018.