5 From Patient Value Strategy to action in bone

  • Working with stakeholders to understand the importance of fragility fractures
  • Bring Evenity™ (romosozumab) to patients living with osteoporosis at high risk of fracture
  • From genetic insight of an Afrikaner population
  • 1 in 3 women and 1 in 5 men over 50 are at risk of a fragility fracture due to osteoporosis13
  • A long-standing partnership with Amgen
  • 4 key studies including over 12 000 patients

From genetic insight on bone growth to an innovative antibody

World Osteoporosis Day 2018

The origin of UCB’s anti-sclerostin program was the genetics of a small population of Afrikaners suffering from the rare, inherited condition of sclerosteosis, which is characterized by bone overgrowth throughout life.

In 2001, UCB reported a proprietary new target using molecular analysis, establishing that the condition of sclerosteosis development is due to the absence of sclerostin, a naturally occurring protein that regulates the rate of bone formation. This provided the stimulus for our research in this area.

In 2004, we partnered this project with Amgen, a company with an existing expertise in the area of osteoporosis. Since then, we have conducted further research and developed a monoclonal antibody called Evenity™ (romosozumab). Evenity™ binds and inhibits the protein sclerostin, resulting in a dual effect on bone: increasing bone formation and decreasing bone resorption. This dual effect differentiates it from other treatments in the field of osteoporosis.

In 2017, a robust clinical development program was completed, evaluating the efficacy and safety of Evenity™ on more than 12 000 patients. This substantial data set has been submitted to healthcare authorities in different countries and UCB expects feedback in the near future. Early 2019, we achieved a first milestone with the approval for Evenity™ in Japan.

Today, 1 in 3 women and 1 in 5 men over 50 are at risk of an osteoporotic fracture. Every 3 seconds someone breaks a bone due to osteoporosis, this adds up to almost 9 million fractures happening every year13. A fragility fracture is commonly the first sign of osteoporosis. Thus, the first fracture should be taken as an important warning sign. It should lead patients to talk with their doctor to inquire about osteoporosis and determine whether they require therapy. This is an important step as 80% of those who experienced a fracture are not identified, nor treated for osteoporosis14.

Here are the major milestones we reached or plan to reach:

Grow & Prepare
(2015-2018)

Phase 3 results
Filing

Accelerate & Expand
(2019-2021)

  • approval (Japan – Jan 2019)
  • regulatory decision (EU & U.S. – Q2 2019)
  • launch in various countries across the world

Breakthrough & Lead
(2022-2025)

Evenity™ is the trade name of romosozumab which has been provisionally approved by the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA).

13 International Osteoporosis Foundation – What you need to know about osteoporosis factsheet – Accessed 4 February 2019

14 Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis: underrated, underdiagnosed and undertreated. Med J Aust 180:S18

Manorama, living with osteoporosis