Lilly's Evista Approved for Marketing in European Union
Two-Year Data Show Osteoporosis Drug Reduces Fracture Risk, Results to
be Presented in September
INDIANAPOLIS, Aug. 5 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY -
news) announced today that it has received approval from the European
Commission (EC) to market Evista(R) (raloxifene hydrochloride) in 15
European Union member countries for the prevention of vertebral (spine)
fractures in postmenopausal women at increased risk for osteoporosis.
''Lilly is proud to play a role in bringing the first selective estrogen
receptor modulator (SERM) for osteoporosis rapidly to approval status in
the European Union,'' said Gino Santini, president, SERMs and skeletal
products division, Lilly Research Laboratories. ''The EC approval
reaffirms that Evista protects postmenopausal women against
osteoporosis, but also shows that Evista prevents painful fractures
associated with the disease.''
The European Union approval marks the first regulatory review of data
from the ongoing Multiple Outcomes of Raloxifene Evaluation (MORE)
study, a clinical trial designed primarily to evaluate the effect of
Evista on spine fractures and bone mineral density in women who have
osteoporosis. These interim (two-year) data were evaluated in addition
to data from osteoporosis prevention studies. The MORE study enrolled
7705 women in 25 countries worldwide.
Updated analyses from the MORE trial will be presented at the European
Congress on Osteoporosis, scheduled to take place in Berlin, September
11-15, 1998. These two-year interim results are expected to show that
Evista produced a statistically significant reduction in the risk of
spine fractures (by 38-52 percent) in osteoporotic women.
Evista is now available in seven countries for the prevention of
postmenopausal osteoporosis: the US, Mexico, Brazil, Israel, Argentina,
Lebanon and Peru. Product registration is pending in 32 other countries
worldwide. Data from the MORE trial will be submitted to other
regulatory bodies for their review.
Lilly is a global, research-based pharmaceutical corporation
headquartered in Indianapolis, Ind., dedicated to creating superior
healthcare solutions in order to help people live longer, healthy and
more active lives. Women's health is a key area in which the company is
focusing its efforts. Full prescribing information (US version) for
Evista is available at www.evista.com. |
