FDA Approves Treatment for Weight Management in Patients with Bardet-Biedl Syndrome Aged 6 or Older
The U.S. Food and Drug Administration has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Imcivree is the first drug approved specifically for chronic weight management in patients with BBS, a rare genetic disorder associated with early-onset childhood obesity.
Imcivree comes with warnings and precautions: Imcivree is associated with disturbance in sexual arousal; male patients who have an erection lasting longer than 4 hours are instructed to seek emergency medical attention; Imcivree is associated with suicidal ideation and depression; therefore, individuals should be monitored for mood changes and suicidal thoughts; Imcivree is also associated with increases in skin pigmentation, including changes to pre-existing moles; therefore, individuals should undergo a skin examination before and during setmelanotide treatment. The most common adverse reactions include skin hyperpigmentation; injection site reactions; gastrointestinal reactions (nausea, vomiting, diarrhea); and spontaneous penile erection.
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