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  • Bayer seeks EU nod to...

Bayer seeks EU nod to third indication of Darolutamide

Written By : Farhat Nasim Published On 2024-10-15T12:29:10+05:30  |  Updated On 15 Oct 2024 12:29 PM IST
Bayer seeks EU nod to third indication of Darolutamide
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Berlin: Bayer said on Monday that it has applied to the EU's drugs regulator for the use of Nubeqa, also known as darolutamide, in combination with androgen deprivation therapy.
It said the submission to the European Medicines Agency (EMA) was based on positive results from a phase III trial that showed darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46 per cent compared with placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer.
Read also: Bayer submits New Drug Application to USFDA for Elinzanetant for treatment of moderate to severe vasomotor symptoms associated with menopause
The compound is already approved in combination with ADT and docetaxel in over 80 markets around the world, and in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease in more than 85 countries around the world.
Read also: Bayer secures full ownership of Bayer Zydus Pharma
BayerNubeqadarolutamideEuropean Medicines AgencyADT
Source : Reuters
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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