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news.Ligand Pharmaceuticals has announced that its partner Pfizer has submitted a new drug application with the FDA for Fablyn tablets for the treatment of osteoporosis in postmenopausal women.
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Pfizer has included the three-year interim data from the postmenopausal evaluation and risk-reduction with lasofoxifene (PEARL) study in the current new drug application (NDA). Fablyn (lasofoxifene tartrate), formerly Oporia, is a selective estrogen receptor modulator (SERM).
The Ligand and Pfizer collaboration was formed to develop therapies for osteoporosis and subsequently produced lasofoxifene tartrate, an estrogen partial agonist for osteoporosis treatment and other diseases. Pfizer is responsible for the registration and worldwide marketing for Fablyn. Ligand is entitled to a milestone payment upon FDA approval, and would also receive royalty payments equal to 3% of net sales.
John Higgins, president and CEO of Ligand, said: “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. 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.”