Press release about the positive opinion of the CHMP for Fablyn (lasofoxifene):
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for
International Nonproprietary Name (INN): lasofoxifene
On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product FABLYN, 500 μg, film-coated tablets intended for treatment of osteoporosis in postmenopausal women at increased risk of fracture. The applicant for this medicinal product is Pfizer Limited.
The active substance of FABLYN is lasofoxifene, a Selective Estrogen Receptor Modulator (ATC code not yet assigned) whose biological actions are largely mediated through binding to estrogen receptors. This binding results in the activation of some estrogenic pathways and a blockade of others.
Lasofoxifene produces an estrogen-like agonist effect on bone.
The benefits with FABLYN are reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures. In the 5-year pivotal study (PEARL) it was demonstrated in high risk postmenopausal subjects in the age-group 60 -80 years that lasofoxifene 500 μg daily was associated with a significant reduction in the risk of new vertebral fractures. This effect was evident after 12 months of treatment. Treatment was also associated with a reduction in the incidence of non-vertebral fractures but not hip fractures as well as increases in BMD at all important sites. The most common side effects are muscle spasms, hot flush and vaginal discharge. The most serious adverse reaction related to FABLYN was venous thromboembolic events (VTE). An unfamiliar benign endometrial pattern was observed leading to a risk to increase the number of minor uterine procedures; this is specifically addressed in the risk management plan.
A pharmacovigilance plan for FABLYN, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication is: “FABLYN is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).”
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for FABLYN and therefore recommends the granting of the marketing authorisation.