- Telix Pharmaceuticals’ (TLX) marketing authorisation application (MAA) submission in Europe for the registration of Illuccix has advanced to the final stage of regulatory review
- Illuccix is a positron emission tomography (PET) agent for the diagnostic imaging of men with prostate cancer
- An approved decision notice is scheduled to be delivered no later than March 23, 2022, following a thorough assessment procedure
- The Danish Medicines Agency (DKMA) coordinated the examination of Illuccix on behalf of thirteen European nations, including the United Kingdom
- Shares in TSX last traded at $7.50 on December 9
Telix Pharmaceuticals’ (TLX) marketing authorisation application (MAA) submission in Europe for the registration of its investigational medication Illuccix has advanced to the final stage of regulatory review.
An approved decision notice is scheduled to be delivered no later than March 23, 2022, following an assessment procedure.
Telix is a biopharmaceutical firm that specialises in the development of diagnostic and therapeutic products utilising molecularly targeted radiation.
Illuccix is a positron emission tomography (PET) agent for the diagnostic imaging of men with prostate cancer.
The Australian Therapeutic Goods Administration (TGA) has approved Illuccix for prostate cancer imaging, and the US Food and Drug Administration has also accepted it for filing.
The Danish Medicines Agency (DKMA) coordinated the examination of Illuccix on behalf of thirteen European nations, including the United Kingdom, as a reference member state (RMS). Telix has chosen these territories for MAA submission.
Following the DKMA’s decision, national-stage approvals for individual member nations are scheduled to begin within 30-60 days following notice.
Telix EMEA President Richard Valeix thanked DKMA for the collaborative interactions throughout the review process
“We are pleased to have confirmation that the so-called “clock-stop” period has concluded, putting us on track for decision in early 2022,” he said.
“PSMA-PET imaging is arguably one of the most important developments in prostate cancer in recent years, we look forward to bringing this next-generation diagnostic tool to patients across Europe, once approved.”
Shares in TSX last traded at $7.50 on December 9.