Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug
Amgen $AMGN and its Belgian partners at UCB may have won over the FDA, but the EMA is still not convinced by their bone-building osteoporosis drug romosozumab.
On Friday, the companies disclosed that the European regulator had adopted a negative opinion on the drug, branded Evenity, for the treatment of osteoporosis in men and in postmenopausal women at increased risk of fracture. The partners plan to appeal the decision.
Evenity was tested in three late-stage studies: the 7,180-patient placebo-controlled FRAME study in postmenopausal women with osteoporosis; the 4,093-patient ARCH study in postmenopausal women in osteoporosis, which tested the drug against Merck’s Fosamax; and the 245-patient placebo-controlled BRIDGE study in men with osteoporosis.
All three pivotal studies showed the monoclonal antibody was effective, but serious CV adverse events were observed in the ARCH trial, which prompted the FDA to originally issue a complete response letter to deny approval in postmenopausal women with osteoporosis. The manufacturers then re-submitted an application to market the drug last year, but for a narrower patient population: postmenopausal women with osteoporosis who carry a high risk of fracture, or patients who have failed or are intolerant to existing osteoporosis therapies.
In April, the US health regulator approved Evenity with a black box warning, highlighting the potentially heightened risk of heart attack, stroke and cardiovascular death. The once-monthly drug carries an annual list price of $21,900 in the United States. The injectable treatment has also been cleared for use in Japan, South Korea and Canada.
“Following regulatory challenges in the US (UCB has previously discussed this possibility with investors), today’s news was not completely unexpected – the partners view EU as the least valuable region in terms of Evenity, and we estimate that the EU opportunity is worth $1-2 per share,” Credit Suisse analyst Evan Seigerman wrote in a note.
Evenity could still win European approval with its appeal, but European sales are expected to be modest, he added.
The drug functions predominantly as a bone anabolic agent that stimulates bone growth by inhibiting a protein called sclerostin, which ceases the production of bone and enhances its breakdown. Prolia, Amgen’s $AMGN older and Europe-approved osteoporosis treatment, is intended for chronic treatment. It works by increasing bone mass for as long as the patient receives it. Evenity is intended for short term use — 12 months — 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.
Social image: Kristoffer Tripplaar, AP Images