The company published promising Phase 3 results from a study evaluating the safety and efficacy of Prolia for patients diagnosed with glucocorticoid-induced osteoporosis. It was compared with risedronate, which is another drug that targets osteoporosis.
A total of 795 patients enrolled in this 24-month-long study. Investigators administered 60 milligrams subcutaneously of Prolia to participants while two other patient subpopulations took daily 5 milligrams of oral risedronate, according to Amgen’s announcement.
Prolia achieved both primary and secondary endpoints at 12 months. It had a stronger showing when it came to restoring bone mineral density at the lumbar spine and total hip regions with reported cases of adverse events and serious adverse events being consistent with Prolia’s current safety profile.
“The impact of glucocorticoid therapy on bone strength is frequently underestimated, and often leads to increased bone loss and ultimately, a fracture,” said Dr. Sean E. Harper, Amgen’s executive vice president of Research and Development in a statement.
“We are excited that these data support the potential for Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease,” added Harper.
This study is still ongoing, but it bodes well for Amgen, wrote FiercePharma. Prolia is slated to break the $1 billion blockbuster sales mark this year as it brought $286 million in sales so far this year. The drug made $837 million in 2015 too.