Bayer's New FDA Application Reflects Orion’s Market Success
Bayer Submits Application to Expand Darolutamide's Use
Orion Corporation recently celebrated an important milestone in the pharmaceutical industry as Bayer, its collaboration partner, submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA). This application aims to expand the use of darolutamide, an oral androgen receptor inhibitor, in combination with androgen deprivation therapy (ADT) for patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).
Positive Trial Results Foster Application Submission
This significant step follows the encouraging results recorded from the pivotal Phase III ARANOTE trial. The study indicated that the combination of darolutamide and ADT remarkably reduced the risk of radiological progression or death by an impressive 46% when compared to the placebo group receiving only ADT.
Global Status of Darolutamide
Currently approved in over 80 markets globally under the brand name Nubeqa®, darolutamide is already a crucial option in the treatment of mHSPC when used alongside ADT and docetaxel. Furthermore, it has attained approval for use in non-metastatic castration-resistant prostate cancer (nmCRPC) patients who are considered at high risk of developing metastatic disease in more than 85 countries.
Celebrating Blockbuster Status
A noteworthy accomplishment was announced by Bayer: the in-market sales of Nubeqa® surpassed a remarkable one billion euros year-to-date, solidifying darolutamide’s position as the first-ever product originating from Orion to achieve blockbuster status. Liisa Hurme, President and CEO of Orion Corporation, expressed pride in this achievement, emphasizing the consistent high-quality research and development efforts that have led to this historic milestone.
The Future of Orion Corporation and Darolutamide
Looking ahead, Orion's prospects seem bright with darolutamide. The ongoing commitment to innovation is reflected in their improved clinical and research pipelines, positing the company favorably to address the varied unmet medical needs of patients with new and innovative therapies.
Contact for More Information
For inquiries, you can reach out to Tuukka Hirvonen at Orion Corporation's Investor Relations.
Orion Corporation's Legacy
Orion stands tall as a globally-operating Finnish pharmaceutical company, nurturing well-being for over a century. The company is engaged in developing, manufacturing, and marketing both human and veterinary pharmaceuticals and active pharmaceutical ingredients. With a diverse portfolio encompassing proprietary and generic medicines as well as consumer health products, Orion focuses primarily on oncology and pain management in its research and development efforts.
Products developed by Orion cater to a wide range of ailments, including cancer, neurological disorders, and respiratory issues. The net sales reported by Orion in 2023 reached an impressive EUR 1,190 million, with around 3,600 dedicated employees transforming healthcare experiences across the globe. Orion’s A and B shares are traded on Nasdaq Helsinki.
Frequently Asked Questions
What is darolutamide used for?
Darolutamide is an oral androgen receptor inhibitor used in combination with androgen deprivation therapy for prostate cancer.
Why is the recent FDA application significant?
The application aims to expand the use of darolutamide for metastatic hormone-sensitive prostate cancer, potentially improving treatment options.
What milestone has darolutamide achieved?
Darolutamide is the first Orion-originated product to exceed one billion euros in global sales, marking its blockbuster status.
Who collaborated with Orion on darolutamide?
The development of darolutamide has been a joint effort between Orion Corporation and Bayer.
What is Orion Corporation known for?
Orion is a Finnish pharmaceutical company known for its innovation in human and veterinary pharmaceuticals, particularly in oncology and pain management.
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