MDNN: ASD Rates Going Up, Hand Washing for C. Diff, and PROMISE 1 Results

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

KEVIN: The CDC has announced new study reports that among observed 8-year-old children in 11 US communities, an estimated 1 in 59 was identified as having autism spectrum disorder — an increase from the 1 in 68 reported in 2016. The data, collected from communities in Arizona, Arkansas, Colorado, Georgia, Maryland, Minnesota, Missouri, New Jersey, North Carolina, Tennessee, and Wisconsin, represents roughly 8% of all 8-year-old children in the United States. The prevalence of autism varied among the sites, from 13.1 to 29.3 per 1000 children, while also varying by race, ethnicity, and sex. Males were found to be 4 times as likely to be diagnosed as females. White children were more likely to have autism compared to black children, and both groups were more likely to be diagnosed than Hispanic children.

MATT: An Australia-based economic evaluation suggests that improved patient hand washing and hospital cleanliness are the most beneficial and cost-efficient measures for reducing C. difficile infection. The infection, which currently causes an estimated 15 to 25% of antibiotic-associated diarrhea cases, also currently costs anywhere from $3,400 to $18,000 in care of each case. According to a recent study published in PLOS ONE, C. difficile mortality has increased from 1.5% in the late 1990s, to more than 4.5% in recent years. Kevin, go wash your hands.

KEVIN: Yikes, I’m way ahead of you. New 12-month data from a phase 3 trial testing the efficacy of eptinezumab for the prevention of migraines has shown the CGRP-targeting therapy is capable of reducing migraines at 2 different doses. The results from Alder Biopharmaceutical’s PROMISE 1 clinical study demonstrated reductions in migraine following quarterly infusions of both 100 mg and 300 mg eptinezumab versus placebo in patients with episodic migraines. PROMISE 1 also reported a comparable safety profile to that of previous trials involving eptinezumab. The news bodes well for the therapy, as Alder hopes to have it approved by the FDA as the first migraine infusion therapy. Hey Matt, talk about PROMISING results!

MATT: Go wash your hands, Kevin. And now for our weekly segment FDA Roundup, let’s go to Jenna Payesko. Jenna, did you wash your hands?

JENNA: Squeaky clean, Matt.

This week, the FDA granted premarket approval for Medtronic’s Deep Brain Stimulation therapy as an adjunctive treatment for reducing the frequency of partial-onset seizures in adults who are refractory to 3 or more antiepileptic medications. The therapy works by delivering electrical pulses to the anterior nucleus of the thalamus, a target involved in the development of seizures.

They also cleared the Attest Super Rapid Biological Indicator System for use with steam sterilization, adding to the already approved system’s availability to be used with vaporized hydrogen peroxide. The tech can be used with both steam and VH2O2 simultaneously in any incubation well, enabling facilities to simplify, standardize and streamline the sterilization process in the event of surgeries.

Lastly, an FDA panel voted unanimously 17—0 to support the reported favorable outcomes for SIGA Technologies’ oral smallpox therapy tecovirimat, a small molecule antiviral treatment for smallpox. If approved in August of this year, it would be the first available therapy for smallpox.

From a green screen in central New Jersey, I’m Jenna Payesko with FDA Roundup. Back to you guys.

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