43. Imcivree

Rhythm
For a fraction of obesity patients, genetic mutations rather than habits are driving their disease. And, with a new approval for Imcivree, Rhythm Pharmaceuticals is setting out on a path to treat those cases. (Rhythm Pharmaceuticals)

Active ingredient: Setmelanotide
Disease: Obesity caused by rare genetic mutations
Peak sales estimate: N/A
Approved: Nov. 27
Company: Rhythm Pharmaceuticals

The scoop: For a fraction of obesity patients, genetic mutations rather than habits are driving their disease. And, with a new approval for Imcivree, Rhythm Pharmaceuticals is setting out on a path to treat those cases. Formerly known as setmelanotide, the med scored an FDA nod to treat patients who have variations of the POMC, PCSK1 or LEPR genes. The drug targets the MC4R pathway responsible for regulating hunger, and the three genes included in the initial approval are just a first step, CEO David Meeker, M.D., said in an interview. The company developed a test that looks at about 100 genetic mutations, and it’s testing the medicine in other genetic mutations with eyes on potential approvals down the line. Rhythm isn’t planning to deploy a sales force for its initial genetic mutations and will instead focus on “intensive efforts” around disease education and making its test more available. When doctors are confronted with a patient with abnormal hunger, they should be “thinking deep” about the cause, Meeker said. – Eric Sagonowsky

43. Imcivree