This is a big day for Amgen, which is taking its case for the bone drug denosumab--as well as hopes for a badly needed mega blockbuster--to a panel of FDA experts. And Amgen is rolling out all its heavy guns.
The biotech giant has a considerable amount of efficacy data on denosumab. But Amgen is likely to face some close questioning on the drug's safety profile. The FDA released a staff review on Tuesday revealing their concerns regarding increased risk of infections and cancer due to the drug's impact on the human immune system. Denosumab inhibits a protein that plays a dual role in both bone destruction as well as immunity. That's why clinical trials revealed a slightly higher rate of infections and some types of cancer for D-mab patients.
To preempt those concerns, Amgen officials this morning pledged to keep a close eye on side effects following commercialization.
"The overall safety profile compares favorably" to other osteoporosis drugs, Dr. Paul Eisenberg, Amgen's senior vice president for global regulatory affairs and safety, told experts this morning. "It will be important that there's long-term follow-up."