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261, 262 Although high rates of efficacy were reported (47 to 64%), given the extremely small combined sample size of fewer than 30 patients, the relatively serious AEs (e.g., new diabetes onset, exacerbation of existing diabetes, pneumonia with septic shock, increased blood pressure), and the known risks of systemic long-term glucorticoid use, risks/burdens clearly outweigh benefits and the Panel recommends that this therapy not be used long-term

Last year, FDA called on PCAC to evaluate whether a dozen peptide drugs should be eligible for compounding by licensed facilities

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