Amgen files new application on bone drug denosumab, hoping to market drug to cancer patients

Amgen seeks cancer approval for bone loss drug

THOUSAND OAKS, Calif. — Amgen Inc. said Friday it filed a new marketing application for its drug candidate denosumab, asking regulators to approve it as a treatment for bone damage suffered by cancer patients.

Amgen is asking the Food and Drug Administration to approve denosumab to prevent or treat damage caused by tumors that spread to the skeleton, or bone metastases.

When tumors spread to the bone, the bones become weaker, which can cause fractures and compression that require surgery or radiation therapy.

Amgen said bone metastases occur in about 1.5 million cancer patients per year, most often in people with prostate, lung or breast cancer.

Amgen said it will also apply for approval in the European Union, Switzerland, Canada, Australian and Japan. In Japan, Amgen is partnering with drug maker Daichii Sankyo.

Denosumab is seen as a possible blockbuster that could recharge the biotechnology company’s revenue growth. In August, Amgen asked the FDA to approve the drug as a treatment for osteoporosis caused by menopause. The agency is scheduled to make a decision on that application by July 25. If the drug is approved, Amgen will sell it under the name Prolia.

In aftermarket trading, Amgen stock lost 12 cents to $54.57. The shares fell 2.1 percent to $54.69 during the regular session.