$ 8 billion price tag for PCOS; Update of the Tymlos label; Genetic Obesity Tx Seeks Further Approvals

The estimated cost to diagnose and treat women with Polycystic Ovary Syndrome (PCOS) was $ 8 billion in the United States in 2020. It is often misunderstood or overlooked by clinicians and policy makers, ”said the Study author Carrie Riestenberg, MD, of the University of California, Los Angeles, in a statement. (Journal of Clinical Endocrinology and Metabolism)

After seeing positive results in a pivotal clinical study, Retina-AI Health announced that it has submitted an application to the FDA for authorization of RETINA-AI Galaxy, its stand-alone diabetic retinopathy screening device.

Weight loss also helped preserve fertility in obese boys aged 10 to 18 by reversing the damage to Leydig cells. (American News and World Report)

Radius Health has announced an update to the label of abaloparatide for the treatment of postmenopausal osteoporosis (Tymlos) to include new data on the drug’s mechanism of action, which now reads: osteoblastic activity. “

Metformin was able to prolong pregnancy by about a week in women with premature preeclampsia. (BMJ)

A new review has supported intermittent fasting – eating only within an 8-10 hour window each day – as a viable method for weight control and metabolism. (Endocrine examinations)

Rhythm Pharmaceuticals has announced that it has submitted an additional new drug application to the FDA to expand the indication of its melanocortin 4 receptor agonist (MC4R) setmelanotide (Imcivree) to also include patients with Bardet syndrome -Biedl or Alström syndrome.

In related news, Rhythm also said that setmelanotide (Imcivree) – already approved by the FDA in 2020 – has now been given the green light in Britain, indicated for chronic weight management in patients aged 6 and over. more suffering from obesity due to a confirmed POMC. , PCSK1 or LEPR deficiency.

Bayer has announced that its new FIND-CKD trial – a Phase III study testing finerenone (Kerendia) in the progression of non-diabetic chronic kidney disease – is now underway. The anti-mineralocorticoid agent was approved in July to reduce the risk of declining kidney function, kidney failure, cardiovascular death, non-fatal heart attack, and hospitalization for heart failure in adults with heart failure. chronic kidney disease associated with type 2 diabetes.

  • Kristen Monaco is editor-in-chief, specializing in news in endocrinology, psychiatry and nephrology. Based in the New York office, she has been with the company since 2015.

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