Pfizer has submitted a New Drug Application to the US Food and Drug Administration for Fablyn, a potential treatment of osteoporosis in postmenopausal women, says partner Ligand Pharmaceuticals.
Fablyn (lasofoxifene), formerly known as Oporia, is a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women. The file includes three-year interim data from the PEARL study and Ligand chief executive John Higgins said the product “provides an attractive treatment option for patients with osteoporosis”.
He added that “Fablyn’s progress is a clear representation of Ligand’s expertise in the area of SERM discovery and research as well as Pfizer’s commitment to this product”. The New York-based behemoth is responsible for the registration and worldwide marketing for the drug and Ligand is entitled to a milestone payment upon FDA approval, as well as royalties equal to 3% of net sales.
However it has to be noted that Pfizer has not had much luck in its previous attempts to get Fablyn on the market. It received not-approvable letters from the FDA for the drug for the prevention of post-menopausal osteoporosis in September 2005 and another for the treatment of vaginal atrophy in January 2006.
