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Astellas and Amgen Astellas' Evenity (romosozumab) Receives MHLW Approval for Patients with Osteoporosis at High Risk of Fracture in Japan

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Astellas and Amgen Astellas' Evenity (romosozumab) Receives MHLW Approval for Patients with Osteoporosis at High Risk of Fracture in Japan

Astellas and Amgen Astellas' Evenity (romosozumab) Receives MHLW Approval for Patients with Osteoporosis at High Risk of Fracture in Japan

Shots:

  •  The approval from Japanese Ministry of Health is based on two P-III study FRAME &  BRIDGE assessing Evenity (210mg) vs PBO in 7-180 & 245 postmenopausal women with osteoporosis & men with osteoporosis respectively for 12 months
  • Evenity (romosozumab) 105mg IV SC is a mAb- indicated for the reduction of    osteoporosis at high risk of fracture in adults- with its MAA filling under review by the US FDA and EMA
  • Amgen Astellas’ Evenity has received its first approval worldwide and third for the    company. In 2004- Amgen and UCB collaborated to jointly develop Evenity worldwide

Ref: Amgen Astellas BioPharma| Image: Astellas


Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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