Regulators in Europe have given the go-ahead to a new indication for Eli Lilly’s blockbuster Forsteo.
The European Commission has approved Forsteo (teriparatide), sold in the USA as Forteo, for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. The approval came as no surprise given that it follows an initial positive opinion issued in February by the Committee for Medicinal Products for Human Use of the European Medicines Evaluation Agency.
The submission package to support the filing included data from a head-to-head study showed that in patients with glucocorticoid-induced osteoporosis, teriparatide significantly increased lumbar spine bone mineral density from baseline (7.2%) compared to Merck & Co’s Fosamax (alendronate; 3.4%) at 18 months of therapy. Lilly’s drug was authorised for marketing in Europe in 2003 for the treatment of osteoporosis in postmenopausal women at high risk for fracture and received an expanded indication to treat men in 2007.
“Up to 50% of individuals on chronic glucocorticoid therapy will develop bone loss leading to an osteoporotic fracture”, said Steven Boonen, professor of medicine at the Leuven University Centre for Metabolic Bone Diseases in Belgium. He added that this new indication for teriparatide “provides physicians and patients with a new treatment option that builds bone”.
This latest approval should help boost revenues of Forsteo, which is already a big earner for Lilly. Fourth-quarter sales of the drug were up 15% to $198.2 million.
