Duzallo®, a fixed-dose combination therapy for gout, approved in Europe

Aachen (ots) - Today, Grünenthal announced that the European
Commission 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 unmet need in gout treatment is extremely high: The disease
is under-diagnosed, under-treated and significantly reduces the
quality of life for patients," explains Philip Just Larsen, Chief
Scientific Officer at Grünenthal. "An acute attack of gout is a
highly painful episode for a patient to experience. Numerous studies
show that gout and hyperuricemia are conditions associated with an
increased risk of all-cause mortality and in particular
cardiovascular events, compared with a non-gout population. However,
the existing standard of care is insufficient to keep patients' uric
acid levels under control. Lesinurad, with its innovative and
selective action, has the potential to help improve control of uric
acid serum levels - which may substantially improve patients' quality
of life."

Mark Fladrich, Chief Commercial Officer at Grünenthal, adds: "We
are proud to bring Duzallo®, 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. For these reasons, we believe that Duzallo® may
become a standard and more convenient treatment option for both
patients and healthcare professionals."

"Gout has traditionally been seen as an acutely painful arthritic
attack. However, it is a serious chronic disease that may lead to
early death, mainly due to cardiovascular events. Until now, the
treatment options that target the major pathology, renal inefficiency
in excreting uric acid, have been limited. Lesinurad targets exactly
this pathology and along with allopurinol, which reduces production,
leads to a greater decrease in uric acid levels," Professor Fernando
Pérez-Ruiz, Senior Rheumatologist in the Rheumatology Division at
Hospital de Cruces, Vizcaya, Spain, states. He further adds: "As an
FDC, Duzallo will be a welcome solution for this complex disease."

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.

About Grünenthal

Grünenthal is an entrepreneurial, science-based pharmaceutical
company specialized in pain, gout and inflammation. Our ambition is
to deliver four to five new products to patients in diseases with
high unmet medical need by 2022 and become a EUR 2 bn company. We are
a fully integrated research & development company with a long track
record of bringing innovative pain treatments and state-of-the-art
technologies to patients. By sustainably investing in our R&D above
the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered
in Aachen, Germany. We are present in approx. 30 countries with
affiliates in Europe, Latin America and the US. Our products are sold
in more than 100 countries and approx. 5,200 employees are working
for Grünenthal worldwide. In 2017, Grünenthal achieved revenues of
approx. EUR 1.3 bn.

More information: www.grunenthal.com
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For further information, please contact:
Stepan Kracala, Head Global Communications
Tel.: +49 241 569-1335, Stepan.Kracala@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

Original-Content von: Grünenthal Group, übermittelt durch news aktuell