Metabolic Disorders

Zagociguat is a CNS-penetrant sGC stimulator.

Joenja is supplied as 70mg tablets in 60-count bottles; it is expected to be available in early April 2023.

Prevalence of pregnancy and incidence of conception were lower for phentermine-topiramate vs topiramate and other antiobesity meds.

Higher genetically predicted plasma caffeine concentrations linked to lower risk for type 2 diabetes, with 43% of effect mediated by BMI.

Previously, the treatment had been approved for patients 1 year of age and older.

To better understand the new phenomenon of “patient influencers”, the authors conducted interviews with individuals who routinely offer advice on health topics on social media.

The approval was supported by data from the randomized, double-blind, placebo-controlled phase 3 LAVENDER study.

February 2023 Notable Drug Approvals

Eplontersen is an investigational ligand-conjugated antisense medicine.

Eplontersen is an investigational ligand-conjugated antisense medicine.

Kevzara approved for polymyalgia rheumatica; Skyclarys approved for Friedreich ataxia; Emergency authorization granted to at-home COVID-19, flu test; Drug-resistant bacteria virus spiking in the US; FDA clamps down on unlawful xylazine imports.

Skyclarys activates the Nrf2 pathway which is involved in the cellular response to oxidative stress.

CHAPLE disease is a rare genetic disorder caused by mutations in the CD55 gene.

The sNDA is supported by data from the phase 3, placebo-controlled APOLLO-B study.

Velmanase alfa is a recombinant form of human lysosomal alpha-mannosidase intended to provide or supplement natural alpha-mannosidase.

The sNDA is supported by data from the ASSERT study, which included patients less than 17 years old with genetically confirmed Alagille syndrome.

Sibutramine is a controlled substance that was voluntarily withdrawn from the market in October 2010.

The company expects ‘pent-up demand’ for the drug to subside within the next few months

Olezarsen is an investigational LICA antisense medication designed to inhibit the production of apoC-III for patients at risk of disease due to elevated triglyceride levels.

Further, baseline vitamin D-related biomarkers lower for individuals with higher BMI