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New Oncology Indications Give Amgen's Bone Drug Denosumab A Bit Of A Leg Up

This article was originally published in The Pink Sheet Daily

Executive Summary

Concerns laid out in "complete response" letter were addressed with data from other trials.

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Amgen Obtains Broader Label For Denosumab With Oncology Indication

FDA approved Amgen’s bone-strengthening drug denosumab Nov. 18 for its first oncology indication, prevention of skeletal-related events – bone fractures or bone pain requiring radiation treatment – in patients with bone metastases from solid tumors.

Prolia Pricing: Straddling Osteoporosis And Oncology

Amgen's first-in-class Prolia (denosumab) is burdened with a high price point as it joins the competitive and price-sensitive osteoporosis market. With a wholesale acquisition cost of $1,650 a year - including two $825 injections - Prolia will officially cost more than the leading branded drugs Actonel (risedronate), Boniva (ibandronate) and Reclast (zoledronic acid), and it will have to compete against generic versions of the gold standard, alendronate (Merck's Fosamax)

Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?

Amgen will attempt to use data culled from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve FDA's questions about the drug's effects in cancer patients, raised in the agency's "complete response" letter on d-mab's use in treating patients with bone loss due to hormone ablation therapy

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