Bayer gains new MHRA indication for Nubeqa

6 June 2025

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of German pharma major Bayer’s (BAYN: DE) Nubeqa (darolutamide) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

This is the second positive development this week for Nubeqa, which gained a similar indication approval from the US Food and Drug Administration.

Sales of Nubeqa jumped 75% in 2024, hitting 1.52 billion euros ($1.64 billion), as Bayer continues to invest in expanding the product’s use. The firm expects combined revenues from Nubeqa and kidney disease drug Kerendia (finerenone) to exceed 2.5 billion euros in 2025, with Nubeqa alone forecast to peak above 3 billion euros.

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