Sanofi overcomes CDMO issues with sutimlimab approval

The US FDA approval of Enjaymo (sutimlimab) comes 13 months after Sanofi was hit by a complete response letter citing deficiencies at a third-party manufacturer.

The US Food and Drug Administration (FDA) approved Enjaymo Friday, a treatment for patients with rare blood disorder cold agglutinin disease (CAD).

The drug, which will be made available in the US at a wholesale acquisition cost of $1,800 per vial, is a humanized monoclonal antibody designed to selectively target and inhibit C1s in the classical complement pathway – a part of the innate immune system.

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The approval comes 13 months after the original action date of November 13 2020 after the FDA hit developer Sanofi with a Complete Response Letter (CRL) citing “certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing.”

The contract development and manufacturing organization (CDMO) has not been revealed, but at the time Sanofi told us it was working with its partner to resolve the observations.

Sutimlimab – previously known as BIVV009 – was developed by Bioverativ, once Biogen’s hemophilia business that span-out in 2017. Sanofi acquired the firm in 2018 for $11.6 billion, bolstering its hemophilia portfolio with two marketed blood-clotting drugs, Eloctate and Alprolix, as well as adding several candidates including the monoclonal antibody sutimlimab. Bioverativ had used its former owner Biogen for drug substance, product and finished goods.

Sanofi unity

While a week ago, Enjaymo’s approval may have been celebrated by “Bioverativ – a Sanofi Company,” an announcement Thursday brought together the French Biopharma’s businesses under one identity: Sanofi.

Bioverativ, therefore, no longer exists in name, and neither do other Sanofi acquisitions including Sanofi Pasteur and Sanofi Genzyme as part of a “transformation” of Sanofi’s business.

“I want to emphasize that as part of the transformation, simply nothing is off the table, including how parts of the business are named, or indeed presented,” CEO Paul Hudson said on an investor call Friday. “Going forward, we’ll be known as Sanofi across our businesses, and we continue to work to raise the standards of disease treatment and prevention.”