The FDA issued a Complete Response Letter for Regeneron’s biologics license application for odronextamab, a bispecific antibody targeting CD20 and CD3 for the treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The rejection was linked to an FDA site inspection at Catalent Indiana, a third-party manufacturing facility recently acquired by Novo Nordisk, according to Regeneron’s second-quarter financial results.
The inspection was not specific to odronextamab but affected multiple pending FDA applications, the company said.
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