BAYER AG

Bayer plans to market Elinzanetant for menopause hot flushes in the EU, submitted to EMA. Aims to offset revenue gap from expiring patents. Study data shows significant reduction in hot flushes. Potential blockbuster with peak sales > €1 billion. Alternative to hormone therapy for some women.

Bayer submitted a marketing authorization application to the EMA for elinzanetant, a drug for menopause-related disorders, based on Phase III data showing reduced vasomotor symptoms in postmenopausal women. Elinzanetant modulates estrogen-sensitive neurons in the hypothalamus, addressing body heat regulation and sleep disturbances. Bayer also filed applications in Australia, Canada, Switzerland, the UK, and the USA.

Published and updated on 2024-10-15 06:59 GMT.

The hemophilia drugs market focuses on treatments for hemophilia A and B, including factor replacement, gene therapy, and bypassing agents. Key drivers are the increasing prevalence of hemophilia, advances in biotechnology, and heightened awareness of early diagnosis. Major companies include Grifols SA, CSL Behring, and Pfizer, Inc. The market is segmented by treatment type, product, route of administration, and geography, with North America and Europe leading due to advanced healthcare infrastructure and supportive regulatory frameworks. Asia-Pacific is expected to see rapid growth due to improving healthcare facilities and increasing awareness.

Darolutamide plus ADT for mHSPC submitted to EMA; ARANOTE trial showed 46% reduction in risk of radiological progression or death, with 24-month rPFS rates of 70.3% vs 52.1% for placebo. Bayer seeks to expand darolutamide's indication to include mHSPC patients.

Bayer AG submits application to EMA for darolutamide, an oral ARi, in combination with ADT for metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, marketed as Nubeqa, is already approved in over 80 markets for mHSPC and in more than 85 countries for non-metastatic castration-resistant prostate cancer (nmCRPC). Phase III ARANOTE trial results show significant reduction in radiological progression or death risk with darolutamide plus ADT compared to placebo plus ADT.

Bayer submitted an application to the EMA for darolutamide, an oral ARi, in combination with ADT for mHSPC patients. The submission is based on the ARANOTE trial's results showing a 46% reduction in radiological progression or death risk. Darolutamide, marketed as Nubeqa, is already approved in over 80 markets for mHSPC and in over 85 countries for nmCRPC.

Bayer files application with EMA for darolutamide, an ARi, to use with ADT in hormone-sensitive metastatic prostate cancer patients. Darolutamide is already approved in over 80 markets for mHSPC with ADT and docetaxel, and in over 85 countries for nmCRPC with ADT.

Bayer submits application to EMA for darolutamide, seeking approval for use with ADT in mHSPC patients, based on ARANOTE trial results. Darolutamide, jointly developed by Orion and Bayer, is already approved in mHSPC and nmCRPC.

Bayer seeks EU approval for Nubeqa in metastatic hormone-sensitive prostate cancer, based on Phase III Aranote trial data showing significant radiographic progression-free survival (rPFS) improvement. Nubeqa is already approved for mHSPC and high-risk mCRPC, with strong sales growth expected to surpass $1 billion in 2024.