Pfizer has submitted a NDA to the FDA for Fablyn (lasofoxifene tartrate) Tablets (formerly, Oporia), a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in postmenopausal women. Pfizer included three-year interim data from the Postmenopausal Evaluation And Risk-reduction with Lasofoxifene (PEARL) study in the current NDA to support its NDA for lasofoxifene in the treatment of osteoporosis.
   
Pfizer is developing the drug with Ligand Pharmaceuticals Inc. The two companies formed a collaboration to develop therapies for osteoporosis, from which lasofoxifene tartrate was produced. Pfizer is responsible for the registration and worldwide marketing and Ligand is entitled to a milestone payment and royalty payments equal to 3% of net sales, upon FDA approval.
    
“We are pleased that a Fablyn NDA has been submitted for the treatment of osteoporosis as the potential product provides an attractive treatment option for patients with osteoporosis,” said John L. Higgins, president and chief executive officer of Ligand Pharmaceuticals. “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.”