US biotechnology major Amgen received a boost recently when the company announced positive results from a pivotal head-to-head Phase III study that was conducted with the firm's main pipeline candidate, denosumab. The study compared denosumab with Swiss drugmaker Novartis' Zometa (zoledronic acid) in the treatment of bone metastases in 1,901 patients with advanced prostate cancer.
The company recently said it expects to submit its response soon to the US Food and Drug Administration regarding a complete response letter it received for its denosumab in the treatment and prevention of postmenopausal osteoporosis (The Pharma Letter January 13). The proposed trade name for this indication is Prolia. Analysts at Zacks Equity Research believe approval for this indication could come in the second half of 2010.
Strong potential in osteoarthritis
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze