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At AACE 2017, John Bilezikian, MD, discussed the latest FDA approval of Tymlos for postmenopausal women with osteoporosis and for women who are at high risk for fracture.
At AACE 2017, John Bilezikian, MD, Professor of Medicine and Pharmacology at the College of Physicians & Surgeons, Columbia University, Chief, Emeritus, of the of the Division of Endocrinology and Director of the Metabolic Bone Diseases Program at Columbia University Medical Center discussed the latest FDA approval of Tymlos for postmenopausal women with osteoporosis at high risk for fracture.
“The development of this drug was very beautifully designed, and it turns out as the clinical trials were developed, that this drug proved itself, that it did do what we thought it would do.” Tymlos was found to markedly increase bone density in a very significant way and reduce fractures in postmenopausal women both at and outside the vertebral column.
“In our field, osteoporosis, we have not had a new FDA-approved drug since 2010, and that’s big news. The other big news is that this drug is a different drug from virtually every other drug we have available for the treatment of osteoporosis.”
Tymlos is part of a new class that represents the second in a class of drugs called osteoanabolics or anabolics — the term meaning that the drug actually builds bone. It builds up bone and improves bone density and as a result reduces that person’s risk of a fracture. “This is a very important feature when we talk about a disease in which bone is broken down.”
Bilezikian explained that the drug was developed with a specific idea in mind, so there weren’t any surprising findings. The team aimed to take advantage of a property of the PTH molecules in a way that was based on protein chemistry. They wanted to create a molecule that had features that would prove to be markedly anabolic and allow doctors to use it safely to build bone.
He stressed that this isn’t a new standard of care; it’s another option. “Medicine is an art to tailor our treatments to what our patients need. And the availability of Tymlos now gives us a very attractive alternative for many women with post-menopausal osteoporosis.”
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