FDA Reviewers Flag Leptin Shot AEs

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Northerner

Admin (Retired)
Relationship to Diabetes
Type 1
The investigational leptin analog metreleptin (Myalept) is most effective for patients with generalized lipodystrophy -- more so than for partial forms of the disease -- but raises concerns about side effects such as lymphoma and immunogenicity, FDA reviewers said.

In documents released ahead of a Wednesday meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, reviewer Julie Golen wrote that patients with "generalized forms of lipodystrophy and significant insulin resistance appear to achieve the best results, including large, and in some cases, sustained improvements in HbA1c and triglycerides."

In contrast, those with partial forms of lipodystrophy have a "more varied, attenuated, and confounded response," Golen wrote.

http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/43354
 
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