Imcivree Considered for Expanded Label; Semglee Hits Shelves; Buphenyl for T2D?

The FDA accepted a priority review of a supplemental new drug application for setmelanotide (Imcivree), a melanocortin-4 receptor agonist, for the treatment of Bardet-Biedl syndrome and Alström syndrome, Rhythm Pharmaceuticals announced. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2022.

AstraZeneca pulled dapagliflozin (Forxiga) for patients with type 1 diabetes in the U.K. and European Union — where it’s approved for this indication — and JDRF International is demanding answers. In the U.S., this SGLT2 inhibitor (sold under the brand name Farxiga) was turned down by the FDA in July 2019 as an adjunct to insulin for type 1 diabetes.

Following the July approval of the first interchangeable biosimilar insulin product for diabetes, Viatris and Biocon Biologics announced that Semglee (insulin glargine-yfgn) injection and unbranded Insulin Glargine (insulin glargine-yfgn) injection are now available in the U.S.

After getting the green light from the FDA, Paracrine announced plans to initiate its pivotal ASCEND trial testing its Celution System for diabetic foot ulcers.

In other trial news, Saniona announced it just initiated a phase IIb trial of its investigational hypothalamic obesity treatment Tesomet — a fixed-dose combination of tesofensine, a triple monoamine reuptake inhibitor, plus metoprolol, a beta-1 selective blocker.

A new correspondence in the Lancet Diabetes & Endocrinology detailed just how COVID-19 targets the adrenal glands.

In a large post-marketing study, 90% of patients prescribed teprotumumab-trbw (Tepezza) for thyroid eye disease adhered to a complete 8-infusion regimen, Horizon Therapeutics announced at the American Academy of Ophthalmology annual meeting.

And, in related news, Viridian Therapeutics said the FDA gave the OK to test its IGF-1R antibody treatment VRDN-001 for thyroid eye disease in a phase I/II proof-of-concept trial.

The first handful of diabetic macular edema patients have been dosed with OCS-01, an investigational topical dexamethasone eye drop treatment in the phase III DIAMOND trial, Oculis announced.

A small study, part of Preprints with The Lancet, found that treatment with sodium phenylbutyrate, a BCAA catabolism accelerator approved under the trade name Buphenyl for urea cycle disorders, significantly improved peripheral insulin sensitivity and glucose oxidation in people with type 2 diabetes.