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Clinically validated examples of in silico and structure-based approaches contributing directly to approved therapeutics include the development of HIV protease inhibitors in the 1990sthe first drugs designed using computational structureactivity relationshipsand the more recent application of GPCR crystal structures to guide ligand optimization for receptors, including the 2-adrenoceptor and GLP-1 receptor (Zhao et al., 2020)
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27 New Indications : A 505(b)(2) sponsor can focus on a carve-out indication, such as obstructive sleep apnea or MASH (metabolic dysfunction-associated steatohepatitis), where the innovators method-of-use patents for obesity or diabetes do not apply
This is usually stress response to rapid weight loss and caloric restriction (telogen effluvium), not direct medication effect
Wegovy and similar GLP-1 receptor agonists were designed for continuous use
Most patients who experience heartburn on GLP-1 therapy have identifiable contributing factors, such as large meal portions, eating close to bedtime, or underlying GERD that may have been previously undiagnosed or inadequately managed
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