* Approved for patients with solid tumors
* Not approved for multiple myeloma
* Shares rise 1.6 percent
(Adds trial detail in ninth paragraph)
By Deena Beasley
LOS ANGELES, Nov 18 The U.S. Food and Drug
Administration has approved Amgen Inc's (AMGN.O) bone drug
denosumab as a treatment for reducing fractures and other bone
problems in cancer patients with solid tumors, a spokeswoman
for the agency said on Thursday.
As expected, the drug, which will be sold under the brand
name Xgeva, was not approved for use in patients with multiple
myeloma, a cancer of the blood, according to FDA's Erica
The solid tumor approval, according to some analysts, is
worth annual sales of more than $1 billion.
Denosumab -- a lower dose of which is currently sold with
the brand name Prolia as a treatment for osteoporosis -- had
sales of $10 million in the third quarter.
Goldman Sachs analyst Sapna Srivastava recently forecast
2013 denosumab sales of $1.3 billion, which is lower than the
average analyst estimate of $2 billion.
The analyst, who rates Amgen shares as "sell," said the
drug's comparatively high price and safety issues will limit
"In Phase III trials, denosumab-treated patients have had
more cases of osteonecrosis (bone death) of the jaw and higher
new malignancy rates versus Zometa," Srivastava said in a
The FDA said denosumab's safety and efficacy was confirmed
in three clinical trials, including a study in prostate cancer
patients which found that the median time to a fracture or
other bone problem was 21 months, compared to 17 months for
patients treated with Novartis AG's NOVN.VX Zometa.
Another trial involving breast cancer patients has
concluded, and also showed that denosumab worked better than
Zometa. The third trial, which involved patients with a variety
of tumor types, including multiple myeloma, showed similar
results for both drugs.
"A diagnosis of bone metastases is a major event for
patients living with cancer, and the consequences can be
devastating," Amgen Chief Executive Officer Kevin Sharer said
in an emailed statement.
Amgen is expected to announce before the end of the year
results from a critical trial looking at whether denosumab can
prevent prostate cancer from spreading to bone. That indication
could add billions of dollars more in sales.
Denosumab is the first in a new class of medicines that
work by blocking a protein which activates bone-destroying
cells called osteoclasts.
Shares of Amgen, which rose 2.4 percent in regular trading,
were up another 1.6 percent at $56 in after hours trading.
(Editing by Carol Bishopric)