Anatara Lifesciences (ASX:ANR) has achieved a significant milestone in the US after receiving a 'complete' letter from the FDA for the Technical Section of its Human Food Safety (HFS) submission.
According to the company, the HFS is a major component of a New Animal Drug Application (NADA) that is currently underway and necessary for enabling the marketing of Detach in the US.
The complete letter confirms the FDA’s Office of New Animal Drug Evaluation, Center for Veterinary Medicine, is satisfied the human food safety requirements for Detach have been met and that food products from animals treated using Detach are considered safe for human consumption.
The HFS Technical Section includes an assessment as to whether Detach will contribute to antimicrobial resistance (drug resistance).
Anatara’s chairman and CEO, Dr Mel Bridges, said, “Safety of edible products from drug-treated, food-producing animals is a critical part of the US drug approval process, so receipt of the complete letter is a core step for the entry of Detach into world markets."
The efficacy, overall safety and manufacturing information required for the approval of human and animal drugs is very similar, but the safety of a drug targeted at food-producing animals must undergo an additional level of stringent review to ensure that there are no residual safety issues for the human consumer.
The Human Food Safety section of the registration process can alone take from three to six years to complete, and can represent 50-70 per cent (or between $5 to $8 million) of expenditure for a new drug.
"The fact that Anatara has achieved an outcome within three years of opening our Investigational New Animal Drug application is an outstanding result and speaks to the strong safety profile we’ve seen for Detach in our trials," said the company.