Authorities in the US have approved the use of a new treatment for women undergoing IVF, in a major boost for its South Australian developers.
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The US Food and Drug Administration (FDA) last month granted approval for EmbryoGen to be marketed in the US, clearing the way for its use in one of the world’s biggest markets.
“I hope this means it is taken up in the IVF market in the US,” co-developer Professor Sarah Robertson, from the University of Adelaide’s Robinson Institute, said.
Professor Robertson said EmbryoGen had been launched at the influential American Society for Reproductive Medicine meeting in San Diego, increasing its chances of being used in clinics and hospitals.
EmbryoGen, which improves embryo implantation rates for some women by up to 40 per cent, was developed through a partnership between the University of Adelaide, Adelaide Research & Innovation and Danish fertility company ORIGIO.
It contains a signalling molecule called GM-CSF found naturally in the mother’s tissues that protects the embryo from stress, making it stronger and more robust in the early implantation period and improving the success of IVF treatment.
The US decision follows earlier decisions by authorities in other major markets such as Europe, China and the Middle East to allow the use of the treatment.
“It’s incredibly exciting to see the benefits of our work reach so many people,” Professor Robertson said.
However, Australian authorities are yet to approve the widespread commercial use of EmbryoGen, with ORIGIO still carrying out negotiations with the Therapeutic Goods Administration.
Professor Robertson said the process could take another year, and admitted it was “a bit frustrating.” But she expressed confidence it would eventually be available to help Australians undergoing IVF.
Adelaide Research and Innovation managing director Robert Chalmers said it was great to see University of Adelaide research having a real world impact and making a difference to the lives of people across the globe.
“Getting FDA approval is a great milestone to reach as this is the next step in enabling EmbryoGen to help more women who have suffered the anguish of miscarriage,” he said.
“With EmbryoGen now approved in Europe and the US, we are looking forward to seeing it approved for use here in Australia so it can be offered routinely to women here as well.”
Learn more about the collaboration between ORIGIO and the University of Adelaide here.
