In October 2016, Sanofi received a complete response letter (CRL) for its rheumatoid arthritis candidate Kevzara (sarilumab) after the US Food and Drug Administration (FDA) discovered manufacturing deficiencies at the French pharma’s fill/finish facility in Le Trait, Rouen – located about 100km northwest from Paris.
While the type and scale of deficiencies were not disclosed, Sanofi said at the time they were associated with documentation and processes at the facility, and not related to the safety or efficacy of sarilumab.
And in a conference call to discuss Q4 results yesterday, CEO Olivier Brandicourt said the firm was confident the problems were resolved and a resubmission of the Biologics License Application (BLA) is imminent.
“We've made good progress since our last quarterly earnings call in remediating our fill-finish plant in Le Trait and subject to successful FDA inspection, we plan to resubmit our BLA for Kevzara in rheumatoid arthritis this quarter,” he told stakeholders.
Spokesman Nicolas Kressmann confirmed this, telling in-Pharmatechnologist the Le Trait facility has been declared ‘acceptable’ by the FDA based on Sanofi’s responses to the FDA 483 letters as well as proposed corrective actions.
Kevzara has been developed with immunology partner Regeneron, which manufactures the active pharmaceutical ingredient (API) from its facility in Rensselaer, New York.
Last month, the product was approved by Health Canada, while the European Medicines Agency accepted Kevzara for review in July 2016 and a decision is expected later this year.
The two companies have also collaborated on Dupixent (dupilumab), a potential treatment for atopic dermatitis which is also filled at the Le Trait facility.
According to Brandicort, an FDA decision for the monoclonal antibody is expected by March 29th and – along with Kevzara and combination diabetes product Soliqua (insulin glargine & lixisenatide injection) approved last November – will be one of three key US launches in 2017.