Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

 Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

Shots:

  • The MAA submission is based on P-III ARAMIS study assessing Darolutamide + ADT vs PBO + ADT in 1,509 men with non-metastatic castration-resistant prostate cancer (nmCRPC) in ratio 2:1
  • The P-III ARAMIS study demonstrated improvement in metastasis-free survival (mFS), presented at ASCO GU in San Francisco with NDA filing & application for marketing in US FDA & MHLW, JAPAN respectively
  • Darolutamide (600mg, q2d) is an androgen receptor antagonist, inhibits the growth of growth of prostate cancer cells, with low BBB penetration. Darolutamide is also evaluated in P-III ARASENS study for m-hormone-sensitive prostate cancer

Click here to read full press release/ article | Ref: Zeiss | Image: EMA News

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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