Amgen, Inc. (NASDAQ:AMGN) is seeking to expand the label of its key drug, Xgeva. Given that the drug is a primary revenue driver for Amgen, the company has presented a supplemental Biologics License Application (sBLA) to the U.S Food and Drug Administration (FDA). It is also seeking to amend the marketing authorization to the European Medicines Agency (EMA).
The expansion of the label will be incorporating patients with multiple myeloma. The company already has an approval for the prevention of skeletal-related events (SREs) in solid tumors and particularly in patients with bone metastases.
The sBLA is based on efficiency and wellbeing data from the pivotal Phase 3 ‘482 study
The study, which was conducted internationally, compared Xgeva to Novartis AG’s NVS Zometa (zoledronic acid). The final results illustrated XGEVA as non-inferior to zoledronic acid, meeting the primary endpoint in holding up the time to first on-study SRE in patients with multiple myeloma. The secondary endpoints pointed out at the superiority of XGEVA with an extra endpoint of PFS, or progression free survival.
According to the VP of Research and Development at Amgen Sean E. Harper says, “Bone lesions are a hallmark of multiple myeloma and often result in bone complications, which can be devastating for patients.”
XGEVA and multiple myeloma
XGEVA is one of the notable treatments for hypercalcemia in the U.S. However, it is not a preference for the prevention of SREs in patients with multiple myeloma. On the other hand, reports have it that 114,000 new cases of multiple myeloma are reported every year. The second most common hematologic cancer is characterized by osteolytic bone lesions.
Treatment for bone complications is very limited given that the only option is bisphosphonates the likes of zoledronic acid. That said the need for preventing bone complications cannot be overemphasized especially in patients with multiple myeloma. The disease results in the development of osteolytic lesions with more than 80,000 deaths being recorded every year.
In the meantime, Amgen’s stock was trading at $162.24 a fall of $2.12 or 1.29%.
