On Monday, the Food and Drug Administration issued a new draft guidance that requires drug manufacturers to conduct long-term nonclinical bone quality studies for osteoporosis treatments.
The agency believes these studies are necessary to determine whether the osteoporosis drugs result in poorer bone quality when taken for long periods of time.
Here are five things to know about the draft guidance:
- FDA says studies should be nonclinical as there are currently "no validated and reliable methods for the noninvasive assessment of bone quality in humans," according to the document.
- For drugs targeting postmenopausal osteoporosis — the most common type — the FDA states bone quality studies should be conducted in ovariectomized rats, with more extensive studies following in a large mammal species such as nonhuman primates, sheep or pigs.
- The FDA requires companies to study two animal species for most drug research. However, the agency will allow biological sponsors to only conduct one animal study if some of the common study animals do not have receptors that can interact with the treatment molecule.
- Companies developing anabolic drugs to treat osteoporosis must study the carcinogenetic potential of the drugs. According to the FDA, past studies have shown bone tumor growth in mice when given parathyroid hormone drugs.
- The FDA asks drugmakers to seek early input from its Division of Bone, Reproductive and Urologic Products on their nonclinical bone quality studies.
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