Updated from 10:27 a.m. EDT
said Monday that the first pivotal study of bone drug denosumab in men with non-metastatic prostate cancer met its endpoints. Separately, the company jumped the gun announcing the Food and Drug Administration approved its platelet-increasing drug for ITP patients -- a statement that has been retracted.
Amgen shares edged up 8 cents, or 0.2%, at $51.10 in recent trading Monday.
First, the Not-Quite-Yet Approval
Amgen has retracted the press release it issued this morning that reported the FDA approved its Nplate for treatment of low platelet count in patients with chronic immune thrombocytopenic purpura (ITP), an autoimmune disease that causes bleeding. The expected FDA-decision date is in fact July 23, the company said.
Amgen estimates that roughly 60,000 adult patients have ITP in the U.S. The approval has been broadly expected by investors, according to Deutsche Bank analysts.
Second, the Dmab Study
It's important to note that the denosumab, or dmab, study results announced today are not the highly anticipated dmab data expected later this quarter on women with postmenopausal osteoporosis. The three-year study announced today was conducted on men undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
In the 1,400-patient study, Amgen's drug effected statistically significantly greater increases in bone mineral density at the lumbar spine and non-vertebral sites compared to the placebo at multiple time points -- consistent with prior denosumab studies.
Men treated with denosumab also experienced less than half the incidence of new vertebral fractures compared with those receiving placebo, which was the secondary endpoint. There were also fewer non-vertebral fractures over the 36-month period.
The company said the incidence and type of adverse events were similar between the arms of the study. Serious adverse infections occurred in 5% of placebo and 6% of those receiving dmab.