According to Iliad Biotechnologies, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted Innovation Passport designation to Iliad’s BPZE1 intranasal pertussis vaccine. BPZE1, which is in Phase 2 development, has previously received Fast Track designation from the FDA. The company notes that Phase 2b trials of BPZE1 in both adults and children have demonstrated positive results and that it plans to initiate a Phase 3 trial in 2025.
Iliad Chief Regulatory Officer Amy Fix commented, “The UK Innovation Passport designation is another important recognition of the promise of BPZE1 to address unmet medical needs not satisfied by current pertussis vaccines and further highlights the willingness of key regulatory authorities to support the accelerated development of BPZE1. This designation, in addition to the previously awarded Fast Track designation by the US FDA, offers ILiAD enhanced access to regulators, and the potential for reduced marketing application review timelines and rolling reviews, which could contribute to bringing BPZE1 to the UK and US markets as efficiently as possible.”
Read the Iliad Biotechnology press release.
