ECO Animal Health Group (AIM:EAH) told investors it has submitted a marketing authorisation application to the European Medicines Agency for ECOVAXXIN MG, its live poultry vaccine against Mycoplasma gallisepticum.
The AIM-listed animal health company develops and markets branded veterinary products for livestock, and ECOVAXXIN MG is the second vaccine from its proprietary pipeline to seek EU authorisation, following ECOVAXXIN MS, which launched commercially in the EU in July after receiving marketing authorisation ahead of schedule.
If approved, ECOVAXXIN MG would extend ECO's poultry vaccine range across major Mycoplasma infections, sitting alongside Aivlosin, the company's established antibiotic for respiratory and intestinal diseases in pigs and poultry.
ECOVAXXIN MG received a favourable safety assessment from the US Department of Agriculture earlier this year, in March, a step toward US marketing authorisation that remains in progress alongside the EU filing.
"The submission of the EU dossier for ECOVAXXIN MG is an important milestone for ECO and reflects the hard work and commitment of our R&D and regulatory teams," said David Hallas, chief executive officer, adding that the company looks forward to "progressing through the EMA review process and advancing towards a planned launch, while in parallel continuing our work towards US marketing authorisation."
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Mycoplasma gallisepticum causes chronic respiratory disease in chickens and reduced egg production, leading to significant economic losses for poultry producers; ECOVAXXIN MG uses a naturally attenuated live strain shown to be safe for young chicks.
The filing follows a run of pipeline progress this year: ECOVAXXIN MS's EU launch drew on ECO's existing Aivlosin distribution network, with distribution agreements covering EU markets representing more than 220 million layer-birds annually, and in September the USDA confirmed that ECOVAXXIN MS field safety trial data, drawn from more than 170,000 commercial laying pullets across three US sites, met licensure requirements.