MDNN: American Health Trends, the First-Ever Gene Therapy Procedure, and the President's Stance on Opioids

Hi, I’m Matt Hoffman, I’m Kevin Kunzmann, and I’m still Matt Hoffman, and this is MD Magazine News Network — it’s clinical news for connected physicians.

The average American is getting healthier, or maybe not, I’m not sure. An early release of selected estimates from the National Center for Health Statistics annual survey reported that rates of vaccination, physical fitness, HIV testing, and cigarette smoking improved in the United States in 2017. Smoking prevalence has reached a 20-year low, with just 14.1% of adults estimated as smokers last year. However, the estimates also report that diabetes and obesity prevalence in US adults have continued to worsen to their highest rates ever. That said, researchers noted to MD Magazine that the growing annual rate of diabetes has slowed in recent years.

Wow, Matt, that’s great news, but not really. Well, some of it is. I don’t know. This week, the Massachusetts Eye and Ear hospital performed the first ever procedure with an FDA-approved gene therapy to treat a patient with inherited blindness. Luxturna, from Spark Therapeutics, was used in a procedure for a 13-year-old boy from New Jersey who had confirmed biallelic RPE65 mutation-associated retinal dystrophy. The condition leads to vision loss and potential blindness in patients but has been shown to be reversed by the clinical effects of Luxturna. The therapy was originally approved by the FDA last December and is currently approved for use at Massachusetts Eye and Ear, and seven other US medical centers.

This week while discussing new measures to address the opioid epidemic, President Donald Trump called for the implementation of the death penalty for drug traffickers convicted of selling and distributing opioids and similar addictive substances. During the press conference from New Hampshire, one of the states most notably affected by opioid overdose-related deaths in recent years, Trump also shared plans for record-breaking Congressional funding designated to combating the epidemic through programs that develop non-addictive pain therapies. He also shared ideas for an advertisement campaign that would be thematically similar to the anti-tobacco commercial campaign of past years. Kevin, thoughts?

None that are good, Matt. And now, for our weekly segment FDA Roundup, let’s go to Jenna Payesko, who’s only holding the top half of an unplugged microphone. Jenna, you’re going to have to speak loudly.

It’s funny you say that Kevin because the FDA has had a relatively quiet week. On Wednesday, they approved tildrakizumab for the treatment of adults with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy. The treatment from Sun Pharma was approved on the evidence of a pivotal phase 3 clinical development program which tested the inhibitor versus placebo in 900-plus patients. Patients to retrieve the therapy reported statistically significant improvements in skin clearance metrics compared to the control group.

The FDA also approved a Lucentis prefilled injection syringe as a new method to administer the therapy for all forms of diabetic retinopathy in patients with or without diabetic macular edema. The syringe, a 0.3-milligram injection of ranibizumab, is now the first of its kind equipped with an anti-VEGF agent approved by the FDA to be used for the treatment of both diabetic retinopathy and macular edema. The injection form of Lucentis became the first and only FDA-approved therapy for both of those indications in April 2017.

From a whatever you can put on a green screen, I’m Jenna Payesko with FDA Roundup. Back to you guys.

For these stories and more, visit us at mdmag.com. I’m Matt Hoffman, and I’m Kevin Kunzmann. Thank you for watching MDNN.