Endocrine Month in Review: August 2021

FDA Approvals

1. FDA Approves SKYTROFA, First Once-Weekly Treatment for Growth Hormone Deficiency in Children
   With approval awarded to Ascendis Pharma on August 25, lonapegsomatropin-tcgd (SKYTROFA) becomes the first once-weekly injection approved by the FDA to deliver somatropin by sustained release over a 1-week period.
2. FreeStyle Libre 2 App Receives Clearance from US FDA for Diabetes Management
   Abbott announced the FDA's clearance of their FreeStyle Libre 2 iOS app, which the company suggests is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms.

Insulin for All? How Recent Developments Impact Insulin Affordability

This 3-part video series from Diana Isaacs, PharmD, and Lucia Novak, CRNP, explores how news from Walmart and Novo Nordisk and a historic approval from the US FDA impacts insulin affordability.

1. How Walmart and Novo Nordisk's Insulin Initiative Impacts Insulin Affordability, with Diana Isaacs, PharmD, and Lucia Novak, CRNP
   Experts discuss how the launch of ReliOn NovoLog and the involvement of corporate entities could impact insulin affordability in both short- and long-term diabetes management.
2. How the Approval of Semglee Impacts Insulin Affordability, With Diana Isaacs, PharmD, and Lucia Novak, CRNP
   Experts offer perspective on how the interchangeable biosimilar approval of Semglee impacts the cost of insulin and what they think is important for patients, providers, and pharmacists to know about the historic FDA approval.
3. Insulin for All or Insulin for Some? Turning Points for Insulin Affordability, With Diana Isaacs, PharmD, and Lucia Novak, CRNP
   The final installment in our series, Isaacs and Novak discuss how recent developments impact the cost of insulin and whether "Insulin for All" is a meaningful phrase or wishful thinking.

USPSTF Releases Updated Guidance for Screening for T2D, Gestational Diabetes

1. USPSTF Lowers Recommended Screening Age for Type 2 Diabetes
   The US Preventive Services Task Force has issued a B-graded recommendation statement lowering their recommended age for screening for type 2 diabetes from 40 to 35 years.
2. USPSTF Reaffirms 2014 Guidance on Screening for Gestational Diabetes
   The latest recommendation statement reaffirms the USPSTF's 2014 guidance, which included a B recommendation for screening for gestational diabetes at 24 weeks of gestation or after.

Study Draws Link Between Vitamin D Levels and Blood Glucose, BMI and COVID-19 Severity

A substudy of a prospective observational study performed at a hospital in Italy details potential associations of vitamin D levels with BMI and blood glucose and severity of COVID-19.