A week after finally getting its bone building drug across the finish line, Amgen on Monday unveiled the annual price tag carried by the injected osteoporosis treatment Evenity: $21,900.
One in two postmenopausal women in the United States have weakened bones that make them highly susceptible to fracturing. Evenity functions predominantly as an bone anabolic agent that stimulates bone growth by inhibiting a protein called sclerostin, which ceases the production of bone and enhances its breakdown.
The current standard of care for the 10 million Americans with osteoporosis is a family of drugs called bisphosphonates — such as alendronate (originally sold under the brand name Fosamax by Merck $MRK) — which thwart cells called osteoclasts that break down bone tissue, but do not rebuild it.
Last Tuesday, the FDA approved the once-monthly Evenity for postmenopausal women with osteoporosis who carry a high risk of fracture, or patients who have failed or are intolerant to existing osteoporosis therapies with a boxed warning highlighting that the use of the drug may increase the risk of heart attack, stroke and cardiovascular death.
Rival anabolic agents belonging to a class of treatments called parathyroid hormone drugs — Radius Health’s Tymlos (priced at $21,900 per year) and Lilly’s $LLY Forteo (priced at $41,100 per year) — must be taken everyday and have longer courses of therapy. In addition, Forteo generics are looming.
Evenity priced in the United States at $1,825 per dose makes the price for a full course of therapy (12 months) 34% to 74% lower than currently available anabolic agents over their full course of therapy (daily doses for 18-24 months), Amgen $AMGN underscored in a statement on Tuesday.
Evenity will not have a cost advantage, but will instead compete on convenience: monthly injections versus daily and shorter treatment duration, BMO Capital Markets analyst Do Kim wrote in a note on Monday. “Our Evenity estimates remain conservative, with US peak sales of $475 million, given the black box warning for higher CV risk.”
In addition, there are some key differences between Evenity and its rivals.
Although Forteo and Tymlos carry black box warnings for osteosarcoma, the findings were in animal studies and not verified in humans. Evenity’s CV signal was seen in a large late-stage trial. “Although Evenity showed greater bone mineral density improvements than Forteo, we believe the black box warning for CV risk will limit uptake to the highest-risk patients with multiple prior fractures,” Kim wrote in a note last week.
Although Evenity’s label reflects its superior bone building effect, clinical data showed the treatment did not translate into reduced fracture risk for non-vertebral fractures (e.g., hip and wrist fractures) which are the most consequential complications of osteoporosis, SVB Leerink’s Geoffrey Porges pointed out in a note last week. “Tymlos and Forteo had a significant relative risk reduction for non-vertebral fractures of 43-53%, while Evenity had a non-significant reduction of 25%.”
Meanwhile, Prolia, Amgen’s older osteoporosis treatment, is intended for chronic use, as it works by increasing bone mass for as long as the patient receives it. Evenity is used to rapidly increase bone mineral density and reduce fracture risk in patients with imminent risk of fracture; it is then followed by an antiresorptive agent such as Prolia, said Elliott Levy, Amgen’s senior VP of global development, in an interview with Endpoints News ahead of the FDA decision.
In postmenopausal osteoporosis, bone resorption exceeds bone formation, and antiresorptive agents can help restore skeletal balance by reducing bone turnover, primarily at the tissue level.
In the US, one in two women over the age of 50 will experience an osteoporotic fracture — an incidence that surpasses that of heart attack, stroke and breast cancer combined, according to the National Osteoporosis Foundation, which estimates osteoporosis will be responsible for three million fractures resulting in $25.3 billion in costs by 2025.
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