Bayer Applies for New Drug Nubeqa, 46% Risk Reduction Shocks Medical Community!

Bayer AG (BAYGn.DE) announced on Monday that it has submitted an application to the European Union's drug regulator for approval of its product Nubeqa, also known as darolutamide, in combination with androgen deprivation therapy (ADT). The company's move is based on positive results from a Phase 3 clinical trial that showed that patients with metastatic hormone-sensitive prostate cancer who received darolutamide plus ADT had a significant reduction in radiological progression or risk of death, reaching 46 percent, compared with those who received placebo plus ADT.

Nubeqa is approved in more than 80 markets worldwide for use in combination with ADT and docetaxel. In addition, it is approved for use in combination with ADT in more than 85 countries worldwide to treat patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease. These patients are often at serious risk of disease progression, so Bayer's application to the EU, if approved, will provide these patients with a new treatment option that is expected to improve their treatment outcomes and quality of life.