Eli Lilly’s osteoporosis therapy Evista (raloxifene) has scored a win after a US Food and Drug Administration advisory panel gave it the thumbs up to market the drug for reducing the risk of breast cancer in two populations of postmenopausal women.
Indeed, the FDA’s Oncologic Drugs Advisory Committee voted 8-6 and 10-4 to recommend its approval in both postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.
Evista is a selective estrogen receptor modulator, which offers the positive oestrogenic effects on the bone and the heart, without its negative impact on breast and uterine tissue and is currently approved to both treat and prevent osteoporosis. Lilly submitted a new drug application in the USA last November requesting that it evaluate Evista for this new use based on data from approximately 37,000 postmenopausal women over a 10 year-period.
If it receives full approval from the FDA, the market for Evista will become significantly broader as the first and only therapy available to address two leading health issues for postmenopausal women - osteoporosis and breast cancer. In the USA alone, around 180,000 women are diagnosed with invasive breast cancer each year.
As good as tamoxifen?
Some panel members have said that Evista may work as well as tamoxifen – the only approved medicine for the prevention of breast cancer - with less potential for side effects.
More than 52 million prescriptions for Evista have been filled since the FDA approved it in 1997, with sales last year in excess of $1 billion, but sales have started to slip, growing just 1% during the second quarter of this year to $278 million from $275.5 million in 2006.
A final decision from the US drug regulator is anticipated in September.