$8B Price Tag for PCOS; Tymlos Label Update; Genetic Obesity Tx Seeks New Approvals

Eli Lilly is voluntarily recalling one lot of the glucagon emergency kit for low blood sugar with an expiration of April 2022 due to loss of potency, the FDA announced.

The estimated cost to diagnose and treat women with polycystic ovary syndrome (PCOS) was $8 billion in the U.S. in 2020. “Although PCOS affects at least one in seven women and leads to over $8 billion in healthcare costs annually in the United States alone, it is frequently misunderstood or overlooked by clinicians and policymakers,” said study author Carrie Riestenberg, MD, of the University of California Los Angeles, in a statement. (Journal of Clinical Endocrinology & Metabolism)

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

Losing weight also helped to preserve fertility in boys with obesity ages 10 to 18, reversing alterations of Leydig cells. (U.S. News & World Report)

Radius Health announced a label update for the postmenopausal osteoporosis treatment abaloparatide (Tymlos) to include new data on the drug’s mechanism of action, which now reads: “Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.”

Metformin was able to extend pregnancy by about another week in women with preterm pre-eclampsia. (The BMJ)

A new review supported intermittent fasting — only eating within an 8- to 10-hour window each day — as a viable method for weight and metabolic control. (Endocrine Reviews)

Rhythm Pharmaceuticals announced that it submitted a supplemental new drug application to the FDA seeking an expanded indication for its melanocortin 4 receptor (MC4R) agonist setmelanotide (Imcivree) to also include patients with Bardet-Biedl syndrome or Alström syndrome.

In related news, Rhythm also said that setmelanotide (Imcivree) — already FDA approved back in 2020 — has now been given the green light in Great Britain, indicated for chronic weight management in patients ages 6 and older with obesity due to confirmed POMC, PCSK1, or LEPR deficiency.

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

Last Updated September 27, 2021