Viro announced that it has received a Complete Response letter from FDA related to its supplemental Biologics License Application (sBLA) for Cinryze as a treatment for acute attacks of hereditary angioedema (HAE).
FDA has requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA, lacked robustness. In the Complete Response letter, FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies.
Vincent Milano, President and CEO of Viro, said: Though Cinryze is already successfully preventing attacks of HAE in many patients, there remains an unmet medical need for patients suffering from acute laryngeal attacks.
Despite having a statistically significant result using the most conservative intent-to-treat (ITT) analysis, the FDA feels that the data are not robust enough to support approval at this time. We intend to respond to the FDA about our plans, and we will provide an update on the second quarter financial call, he added.