- The Theraputic Goods Administration (TGA) has commenced a priority evaluation process for Telix Pharmaceuticals’ (TLX) prostate cancer imaging product, Illuccix
- Telix is a clinical-stage biopharmaceuticals company with headquarters in Melbourne
- Under a priority pathway, the TGA will evaluate Telix’s submission to list its lead investigational product on the Australian Register of Therapeutic Goods
- It aims to do this within a 150-working-day timeframe, with an indicative decision date of November 12
- Alongside submissions in Canada, the European Union and the United States, TLX presently has regulatory reviews for Illuccix underway in 17 countries
- Telix CEO Dr Christian Behrenbruch says the priority evaluation brings TLX closer to its goal of providing widespread access to state-of-the-art prostate cancer imaging for Australian men
- Telix shares are up 1.98 per cent, trading at $4.12 each
The Theraputic Goods Administration (TGA) has commenced a priority evaluation process for Telix Pharmaceuticals’ (TLX) prostate cancer imaging product, Illuccix.
Headquartered in Melbourne, Telix is a clinical-stage biopharmaceutical company developing a portfolio products designed to address significant unmet medical needs in oncology and rare diseases.
Under a priority registration pathway, the TGA will now evaluate Telix’s submission to list its lead investigational product on the Australian Register of Therapeutic Goods.
The TGA is aiming to complete the evaluation within a target timeframe of 150 working days and has provided an indicative decision date of November 12.
Alongside submissions in Canada, the European Union and the United States, TLX presently has regulatory reviews for Illuccix underway in 17 countries.
Telix CEO Dr Christian Behrenbruch said the company is pleased to see the TGA evaluating its submission as a priority.
“This brings us significantly closer to our goal of providing widespread access to state-of-the-art prostate cancer imaging for Australian men living with prostate cancer,” Dr Behrenbruch said.
“Should we be successful in gaining TGA registration of Illuccix in Australia, we would also anticipate filing a new medical application with Medsafe in New Zealand under the abbreviated evaluation process for medicines approved by recognised overseas regulators,” the CEO added.
According to TLX — and together with the U.S. and Canada — Australia and New Zealand have among the highest rates of prostate cancer in the world.
More than 85,000 Australian and New Zealand men were reportedly estimated to be living with the disease last year.
Telix Pharmaceuticals are up 1.98 per cent, trading at $4.12 at 2:43 pm AEST.