Details on the chemistry, manufacturing, and controls are part of the complete response letter.
FDA requested additional information from Dyax related to approving DX-88 as a treatment of acute attacks of hereditary angioedema (HAE). The agency asked for Risk Evaluation and Mitigation Strategy (REMS) and details with respect to the chemistry, manufacturing, and controls (CMC) section of the BLA.
Dyax points out that the complete response letter does not require additional clinical trials. The firm reports that it previously submitted a proposed Safe Use program, which will be converted into a REMS.
The CMC questions are primarily focused on analytical methodologies as well as specifications and validation activities in support of drug product filling and packaging. Earlier this year, a preapproval inspection of the manufacturing processes, sites and supporting quality systems was successfully completed.