Application For Multiple Indications Submitted By Amgen, Inc. (NASDAQ:AMGN) To US And Europe Regulators

Amgen, Inc. (NASDAQ:AMGN) has revealed that it has submitted an sBLA – supplemental Biologics License Application to the Food and Drug Administration. Additionally, the pharmaceutical giant has also submitted an application to the EMA – European Medicines Agency seeking a variation on the marketing authorization that has already been given for XGEVA or denosumab.

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With the two submissions to the two regulatory authorities, Amgen is seeking to have the indications that have already been approved for XGEVA expanded so that the drug can be used not just to prevent skeletal-related events occurring in solid tumors but to also include cases of patients suffering from multiple myeloma.

New clinical data

In the applications, new data obtained from the phase 3 ‘482 study has been included by Amgen. The study is the biggest multiple myeloma trial that has ever been conducted globally. Adverse events that were observed in the study were consistent with XGEVA’s safety profile. These adverse events included diarrhea which was reported in 33.5% of the trial’s participants compared to 32.4% for trial participants taking zoledronic acid.

XGEVA works by binding to and neutralizing the RANK ligand. This is a protein that is required in order for osteoclasts to form, function and survive. In so doing, XGEVA prevents osteoclasts from destroying bones as they are primarily responsible for the breaking down of bone matter.

Limitation of use

At present XGEVA is indicated as suitable for preventing skeletal-related events in patients suffering from bone metastases caused by solid tumors. This is based on results that were obtained from the late-stage trials. In these studies XGEVA performed better than zoledronic acid in the solid tumors. However, XGEVA has a limitation of use in the United States where it is not indicated as a drug that can be used to prevent skeletal-related events in patients suffering from multiple myeloma. This could change if the regulatory authorities rule in Amgen’s favor.

“XGEVA’s unique mechanism of action may offer multiple myeloma patients a novel treatment option,” Amgen’s Research and Development executive vice president, Sean Harper, said.

On Tuesday shares of Amgen Inc rose by 0.29% to close the day at $164.36.

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