Industry Insights Healthcare
This week’s insights post focuses on three of the most recent developments and discussion points in the healthcare industry.
FDA removes “black box” warning from HRT products for menopause
In January 2003, the FDA issued “black box” warnings for HRT medications based on the Women’s Health Initiative study with warnings about the potential increased risk for health conditions like breast cancer, dementia and cardiovascular disease when taking HRT. This led to decades of fear and misinformation limiting women’s access to treatment for symptoms like hot flashes, sleep disturbance and mood changes. In addition to removal of the boxed warnings, the FDA is also approving two new drugs to expand safe and accessible treatment options for menopausal symptoms.
Link to announcement
One cup of coffee may reduce atrial fibrillation recurrence risk by 39%
Researchers have found that drinking one cup of caffeinated coffee a day may reduce a person’s risk of recurrent atrial fibrillation (AF) by up to 39%. Traditionally, cardiologists have advised those with AF to limit or avoid caffeine intake. In this study, participants were randomised to drink at least one cup of coffee per day or abstain for a period of 6 months. A potential explanation may be that chronic coffee consumption is associated with lower blood pressure via a diuretic effect, with the lower blood pressure protecting against AF. This suggests that cardiologists may be able to change their recommendations in the future.
Link to study
Patient death in Intellia Therapeutics’ gene trial
A patient dosed with Intellia Therapeutics’ CRISPR gene therapy has died after suffering a severe liver-associated adverse event. The therapy, nex-Z (nexiguran ziclumeran), is designed to stop the TTR gene from producing abnormal transthyretrin protein which causes ATTR with cardiomyopathy. In response to the patient’s death, Intellia share prices have plunged nearly 62%. The FDA has placed a clinical hold on the trial following multiple instances of severe liver toxicity in participants. It remains unclear when the TTR trials will resume.
Link to announcement
Want to get in touch? Contact us at https://elion.nz/get-in-touch/
