Health Canada grants priority review for Cycle’s nitisinone tablet filing

JULY 20, 2016
Cycle Pharmaceuticals (Cycle) announced today that Health Canada has granted a priority review for Cycle’s application for approval of Cycle’s nitisinone tablets for the treatment of hereditary tyrosinaemia type-1 (HT-1).  Health Canada’s review of this application is underway.

HT-1 is a rare genetic disease that affects infants from birth. HT-1 patients have problems breaking down an amino acid called tyrosine. Toxic by-products are formed and accumulate in the body, which can cause liver, renal and neurological complications. It is progressive and can be fatal if untreated. There are approximately 1,000 HT-1 patients worldwide, 10 per cent of whom live in Canada.

Nitisinone is a life-long twice-daily treatment for HT-1 patients alongside a strict low-protein dietary regime.

Cycle’s nitisinone tablets are bioequivalent (ie medically equivalent) to Orfadin®, another nitisinone product which is not approved in Canada.

Cycle’s nitisinone tablets can be stored at room temperature. They can also be taken before, during or after food consumption, and they are small in size and easy to swallow.

Antonio Benedetti, CEO of Cycle, commented: “We have worked hard for many years to develop our nitisinone product.  We hope that it will allow HT-1 patients to live as normal a life as possible without constraints imposed by their lifelong nitisinone requirement.  We are pleased that Health Canada has expedited the review of our submission and we look forward to working with all stakeholders as we seek approval of our product.  Given the high HT-1 population in Quebec, Canada is a natural first filing location for Cycle’s nitisinone tablets.

About Cycle Pharmaceuticals

Cycle Pharmaceuticals is a Cambridge-based pharmaceutical company that optimises and increases access to existing pharmaceuticals. Specifically, Cycle focuses on three areas of pharmaceutical development:

  • Improving orphan drugs, which treat the under-served rare disease patient community;
  • Reinstating drug products that have been previously marketed;
  • Working with our academic and other partners to extend pharmaceuticals to new medical areas where there is clear unmet need.

For further information, please visit