- Telix Pharmaceuticals (TLX) sees its review period for its prostate cancer imaging product extended by three months by the FDA
- The extension was a result of the company’s Pre-Authorisation Inspection taking place after its initial late-cycle review meeting, which raised manufacturing-related observations
- The US Food and Drug Administration (FDA) set a revised target date of 23 December 2021 for Illuccix, which will allow the FDA to review and consider further manufacturing-related information submitted by the company
- Telix Pharmaceuticals is down 6.32 per cent, trading at $6.37 at 11:46 am AEST
Telix Pharmaceuticals (TLX) has seen its review period for its prostate cancer imaging product extended by three months by the FDA.
The US Food and Drug Administration (FDA) has set a revised target date of 23 December 2021 for Illuccix, Telix’s new drug application. This will allow the FDA to review and consider further manufacturing-related information submitted by the company, and is considered a standard review extension period.
Telix sat down to a late-cycle review meeting with the FDA in June, during which time the authority indicated there were no substantivate manufacturing or clinical review issues with Telix’s product.
However the date of the company’s Pre-Authorisation Inspection (PAI) was after the meeting and it raised a set of manufacturing-related observations. Telix has since responded to those observations which the FDA is reviewing.
Telix CEO Christian Behrenbruch explained: “The timing of our PAI relative to the late-cycle review meeting meant that additional review time was needed to address manufacturing-related observations”.
“We look forward to being in a position to bring to patients in the US access to this flexible, highly specific and sensitive imaging tool for the detection of prostate cancer,” Dr Behrenbruch said.
Telix Pharmaceuticals was down 6.32 per cent, trading at $6.37 at 11:46 am AEST.