MediWound plans to file BLA for NexoBrid in 2H19
"2018 was a pivotal year for MediWound as we made significant progress on several fronts. On the development side, after completing enrollment in our Phase 3 DETECT study of NexoBrid last summer, we announced in January 2019 that we met the primary and all secondary endpoints with statistically significant results compared with the control group," said Gal Cohen, MediWound's President and CEO. "These excellent top-line results corroborated our previous positive European Phase 3 clinical study results and further demonstrate how meaningfully NexoBrid can impact patients' lives. We plan to file the BLA in the second half of 2019, subject to FDA concurrence in a pre BLA meeting planned for the second quarter of 2019. In addition, we expanded our NexoBrid Phase 3 CIDS study in children, to U.S. burn centers after receiving FDA concurrence on the protocol and BARDA funding for the study. For EscharEx, as requested by the FDA, we submitted information on the additional suggested secondary efficacy endpoints, and subject to FDA agreement, plan to advance the EscharEx clinical development program in the first half of 2019."