On January 8, the European Medicine Agency (EMA) accepted Amgen and UCB’s submission for review for use of Evenity (romosozumab), a novel anabolic agent for the treatment of postmenopausal women and men with osteoporosis.

Amgen is already a well-established player in the osteoporosis market, with its RANK inhibitor Prolia (denosumab) increasingly being adopted as a first-line therapy for osteoporosis. Based on the design of its FRAME study, it is clear that Amgen is hoping to position Evenity in conjugation with Prolia, highlighting the potential to transition between the two agents. Interestingly, according to a Phase III trial, the effects of Evenity persisted for one year after patients from the FRAME study transitioned onto Prolia therapy.

If awarded approval, Evenity will enter a market full of competition. Bisphosphates, such as alendronate, have long been accepted as the go-to first-line treatment option for osteoporosis due to their known efficacy and low price tag. However, concerns around the long term use of these agents and compliance issues in many patients persist, emphasizing the need for novel osteoporosis therapies. Rival anabolic agents are also on the market, although they are generally restricted to high risk patients or those in which other therapies are contradicted due to their high cost of therapy. GlobalData expects that Evenity will have to compete against these therapies, and with Radius Health’s marketing authorization application (MAA) for Tymlos (abaloparatide) currently under review by the EMA, it will be a race to market between these two bone-forming agents. GlobalData believes that the price tag of these two agents will be a key distinguisher in the European market.

Despite the fact that it has a strong efficacy profile, the road to approval may not be smooth for Evenity. Amgen previously submitted a biologics license application (BLA) to the FDA based on the data from its FRAME study. However, in July 2017, the FDA issued a Complete Response Letter rejecting the Amgen’s BLA amid safety concerns surrounding increased risk of cardiovascular events during the ARCH study. Based on this, the FDA has requested a resubmission of the application, including data from all three Phase III studies. Despite the FDA’s concerns, key opinion leaders interviewed by GlobalData have rejected any anxieties surrounding this drugs safety, expressing confidence that the drug will receive positive approval and be a welcome addition to their osteoporosis drug portfolios.

Osteoporosis is a chronic disease that affects many individuals over the age of 50, particularly postmenopausal women. It is associated with a high fracture risk, leading to decreased mobility and quality of life due to severe fractures.

Amgen and UCB’s filing is based on data from three pivotal Phase III trials: FRAME, ARCH, and BRIDGE. The novel sclerostin inhibitor is administered as a once monthly subcutaneous injection. In its FRAME and ARCH studies, Evenity reduced the risk of new vertebral fractures in postmenopausal women by 73% and 48% compared to placebo and alendronate, respectively. As such, Evenity’s ability to not only decrease bone resorption but to also increase reformation could offer patients a much needed treatment option.

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