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news.Roche has announced that the FDA has issued a complete response letter for the biologics license application for Actemra, the first interleukin-6 receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
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According to the company, the FDA has not requested any new clinical studies surrounding the efficacy or safety of Actemra as a prerequisite for approval. The FDA has requested additional documentation related to the manufacturing of Actemra and certain other outstanding components, such as final labeling.
Roche said that it is committed to working with the FDA to promptly address any outstanding matters. Upon satisfactory completion of the FDA’s requests and an approved label, Roche does not foresee any issues that would impact the quality, availability and supply of Actemra in the US.
George Abercrombie, CEO and president of Roche, said: “Roche is committed to working with the FDA to make this important new therapy available to rheumatoid arthritis patients as soon as possible. We will continue to work closely with the agency to address its questions and define the path forward for Actemra.”