ECO Animal Health Group plc announced on Wednesday that the United States Department of Agriculture has delivered a favourable safety assessment for its live poultry vaccine ECOVAXXIN MG, marking a key step toward marketing authorisation in the US.
The regulatory review confirmed that the vaccine meets the USDA's safety requirements. Final regulatory submission for ECOVAXXIN MG is currently anticipated in late 2027.
As part of the US registration process, the vaccine was demonstrated to be safe for its target species, chickens, as well as non-target avian species including turkeys and quails. Testing also confirmed the vaccine strain did not revert or increase in virulence after passage through chickens, demonstrating stability.
ECOVAXXIN MG targets Mycoplasma gallisepticum, a bacterial pathogen that causes chronic respiratory disease in chickens and infectious sinusitis in turkeys. The vaccine uses a naturally attenuated strain of the bacterium shown to be safe for young chicks.
ECO Animal Health develops and markets branded veterinary pharmaceuticals globally, specialising in antibiotics and vaccines for pigs and poultry. The company, headquartered in the UK, holds marketing authorisations in more than 70 countries and employs over 200 people worldwide. Its lead product, Aivlosin, is a patented medication used to treat respiratory and intestinal diseases in pigs and poultry.
CStone Pharmaceuticals' sugemalimab granted new indication by UK MHRA
Merck reports positive Phase 3 data for Enflonsia in high-risk children across two RSV seasons
Beyfortus study shows sustained reduction in infant RSV hospitalisations across two seasons
AstraZeneca reports positive Phase III results for BREZTRI in uncontrolled asthma
Akeso's AK139 Phase II clinical trials approved in China
Median Technologies secures FDA clearance for AI lung cancer screening software
Insilico Medicine names new vice president, Clinical Development – Oncology
Cizzle Biotechnology secures Canadian patent for lung cancer biomarker test
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Guerbet's contrast agent Elucirem approved by European Commission in children from birth