Orion’s collaboration partner Bayer submits application for third indication of darolutamide in the EU
14 Oktober 2024 - 10:00AM
UK Regulatory
Orion’s collaboration partner Bayer submits application for third
indication of darolutamide in the EU
ORION CORPORATION
INVESTOR NEWS
14 OCTOBER 2024 at 11.00 EEST
Orion’s collaboration partner Bayer submits application for
third indication of darolutamide in the EU
Orion’s collaboration partner Bayer today announced the
submission of an application to the European Medicines Agency (EMA)
for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer
is seeking approval for the use of darolutamide in combination with
androgen deprivation therapy (ADT) in patients with metastatic
hormone-sensitive prostate cancer (mHSPC). The submission is based
on positive results from the pivotal Phase III ARANOTE trial which
showed that darolutamide plus androgen deprivation therapy (ADT)
significantly reduced the risk of radiological progression or death
by 46% compared to placebo plus ADT in patients with mHSPC.
The compound is already approved in mHSPC, under the brand name
Nubeqa™, in combination with ADT and docetaxel in over 80 markets
around the world. The compound is also approved in combination with
ADT for the treatment of patients with non-metastatic
castration-resistant prostate cancer (nmCRPC) who are at high risk
of developing metastatic disease in more than 85 countries around
the world. Darolutamide is developed jointly by Orion and
Bayer.
Contact person:
Tuukka Hirvonen, Investor Relations, Orion Corporation
tel. +358 10 426 2721
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orion.fi/en
http://www.twitter.com/OrionCorpIR
Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being for over a hundred years. We develop,
manufacture and market human and veterinary pharmaceuticals and
active pharmaceutical ingredients. Orion has an extensive portfolio
of proprietary and generic medicines and consumer health products.
The core therapy areas of our pharmaceutical R&D are oncology
and pain. Proprietary products developed by Orion are used to treat
cancer, neurological diseases and respiratory diseases, among
others. Orion's net sales in 2023 amounted to EUR 1,190 million and
the company had about 3,600 employees at the end of the year.
Orion's A and B shares are listed on Nasdaq Helsinki.
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