Pfizer's Fablyn gets EU positive opinion
This article was originally published in Scrip
Pfizer's selective oestrogen receptor modulator (SERM) Fablyn (lasofoxifene, 500μg film-coated tablets) has been granted a positive opinion by the EU's CHMPfor the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
The go-ahead for EU approval comes while the product is still under extended review at the US FDA, which, in October, prolonged its review by three months to analyse the complete five-year data from the PEARL pivotal study. This followed an endorsement for the product from the US agency's reproductive health drugs advisory panel in September (Scrip Online, October 24th, 2008). Pfizer originally filed lasofoxifene for osteoporosis prevention and vaginal atrophy in 2004 but both NDAs received non-approvable letters form the FDA.
The only other SERM approved for osteoporosis is Lilly's Evista (raloxifene), which has been available for the treatment and prevention of the disorder since the late 1990s. Wyeth is pursuing approval of its SERM candidate bazedoxifene (Viviant), although this received an approvable letter from the FDA requesting further data on the incidence of stroke and venous thrombotic events in May (Scrip Online, May 23rd, 2008). Bazedoxifene was filed for EU approval last year.
THE CHMP says the benefits with Fablyn are reductions in serum and urine levels of bone turnover markers, increases in bone mineral density and decreases in incidence of fractures.
It noted that five-year data from the PEARL study showed that in high-risk postmenopausal women aged 60 to 80 years, 500μg daily significantly reduced the risk of new vertebral fractures. This effect was evident after 12 months of treatment. Lasofoxifene was also associated with a reduction in the incidence of non-vertebral fractures but not hip fractures, as well as increases in bone mineral density at all important sites.
The committee also noted that Fablyn's most serious adverse event was thromboembolic events, and an unfamiliar benign endometrial pattern was observed leading to an increase in risk of minor uterine procedures. "This is specifically addressed in the risk management plan," it said.
The approved indication states that: "When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissue and cardiovascular risks and benefits."