Duzallo EU Marketing Authorization
Grünenthal announced that the European Commission (EC) has followed the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and granted Duzallo marketing authorization for the EU/EEA.
Duzallo is a fixed-dose combination (FDC) therapy that combines allopurinol and lesinurad.
It is indicated for the treatment of hyperuricaemia in adult gout patients who have not been able to reach target levels of uric acid serum with a dose of allopurinol alone. Lesinurad is the first innovative uricosuric in gout treatment for over 40 years.
The marketing authorization has been granted for the 28 European Union member states, as well as for the EEA countries Norway, Iceland and Liechtenstein. The approval by the European Commission is based on the positive opinion adopted by the CHMP of the European Medicines Agency (EMA) in June 2018.
This is a key milestone in Grünenthal’s ambition to build a strong portfolio in gout, where there is a high unmet patient need. In March 2018, Grünenthal’s first gout product Zurampic was launched in Switzerland and Italy. By the end of this year, it will have been launched in other European countries. Duzallo is planned to be launched in most European countries in 2019.
Duzallo is a fixed-dose combination, to patients as it has the potential to elevate the standard of care in gout. While allopurinol decreases the production of uric acid, lesinurad increases its excretion by the kidneys, leading to better control of uric acid levels. Moreover, the fixed-dose combination has an additional benefit for patients by reducing the burden of taking multiple pills. That is the reason, Duzallo may become a standard and more convenient treatment option for both patients and healthcare professionals.
Grünenthal is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Grünenthal is an independent, family-owned company headquartered in Aachen, Germany.