The FDA granted the approval of Imcivree to Rhythm Pharmaceutical, Inc.

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Setmelanotide was approved for medical use in the United States in November 2020.Setmelanotide was approved for medical use in the European Union in July 2021. Research
Setmelanotide is a peptide drug and investigational anti-obesity medication which acts as a selective agonist of the MC4 receptor; the structure of the bound complex has recently been determined. Its peptide sequence is Ac-Arg-Cys(1)-D-Ala-His-D-Phe-Arg-Trp-Cys(1)-NH2. It was first discovered at Ipsen and is being developed by Rhythm Pharmaceuticals for the treatment of obesity and diabetes. In addition, Rhythm Pharmaceuticals is conducting trials of setmelanotide for the treatment of Prader–Willi syndrome (PWS), a genetic disorder which includes MC4 receptor deficiency and associated symptoms such as excessive appetite and obesity. As of December 2014, the drug is in phase II clinical trials for obesity and PWS. So far, preliminary data has shown no benefit of Setmelanotide in Prader-Willi syndrome. References
External links
"Setmelanotide". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02896192 for "Setmelanotide for the Treatment of Early-Onset POMC Deficiency Obesity" at ClinicalTrials.gov
Clinical trial number NCT03287960 for "Setmelanotide for the Treatment of LEPR Deficiency Obesity" at ClinicalTrials.gov
Cochlear hydrops (or cochlear Menieres or cochlear endolymphatic hydrops) is a condition of the inner ear involving a pathological increase of fluid affecting the cochlea. This results in swelling that can lead to hearing loss or changes in hearing perception. It is a form of endolymphatic hydrops and related to Menieres disease. Cochlear hydrops refers to a case of inner-ear hydrops that only involves auditory symptoms and does not cause vestibular issues. Cause and behavior
Cochlear hydrops refers to an increase in endolymphatic fluid in the inner ear. This build-up is either due to an overproduction or insufficient drainage of endolymph in the constant regulation of fluid in the inner ear. Usually, only one ear is affected. The root cause of the process is unclear and may vary from patient to patient, but can have auto-immune, viral, and/or allergic triggers, among others.The build-up of endolymph creates pressure in the scala media. This causes its diameter to increase, and the vestibular membrane to curve outwards in the direction of the vestibule. The changes to the membrane can result in changes to either the hearing perception or hearing threshold of a patient.Episodes are usually cyclical and symptoms fluctuate through time. Patients may be symptom-free between episodes, which themselves may progressively worsen, improve, or remain constant in severity or duration.