FDA Approval of Mavacamten Delayed

The U.S. Food and Drug Administration (FDA) has postponed the date by which it must complete its review of mavacamten – the first drug made specifically to treat HCM. The FDA was originally scheduled to announce its decision in late January 2022, but that date has now been postponed until April 28, 2022, which is the new “PDUFA date” or the date by which the FDA must respond to the new drug application.  

The FDA has not asked Bristol Myers Squibb (BMS) to submit any additional data, but it wants to spend more time reviewing the proposed Risk Evaluation Mitigation Strategy or REMS which is the safety profile of the drug.  The FDA can require REMS for certain drugs with safety concerns to ensure that the benefits of the medication will outweigh any risks.

BMS acquired the drug mavacamten, a first in class myosin inhibitor, through its $13.1 billion acquisition of San Francisco biotech company MyoKardia late last year.

You can read more about mavacamten and its journey in these past entries from HCMBeat:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

HCM Drug Shows Improvement to Heart Structure

More Positive Data on Mavacamten Presented at ACC Meeting

More Positive Results for MyoKardia Drug

MyoKardia Announces Positive Results from EXPLORER Trial

MyoKardia’s EXPLORER Trial Big Success

Mavacamten Approaches Finish Line

Electric & Hybrid Cars: A Safe Choice for ICD & Pacemaker Patients

Car Shopping

Recently, I began shopping for a new car.  The process is overwhelming! There are so many factors to consider when looking for a new vehicle: gas mileage, sedans vs. hatchbacks, SUVs…the list goes on and on.  Electrics and hybrids are all the rage here in Southern California, but I wasn’t sure if they would be safe for me to drive because I have an implantable defibrillator which also functions as a pacemaker.

German Study: Safety of Popular European Electric Cars

Lucky for me, I didn’t have to wait too long for an answer to my question.  According to a recent German study published in the Annals of Internal Medicinepeople with implanted cardiac devices can safely drive the most common electric cars on the market today.  This study measured the magnetic field strength in four electric cars with the largest market share in Europe: the BMW i3, Nissan Leaf, Tesla Model 85S, and the Volkswagen e-up!  Though the study found that recent models of all of these cars were safe, the authors of this study did caution that future models could potentially cause interference with implantable cardiac devices, depending on  their design.

For more on the recent German study, see these articles at Reuters, Medical Xpress.com and TechTimes.

2017 AHA Preliminary Data – Tesla

The findings from the German study added to preliminary data presented at a 2017 meeting of the American Heart Association.

Tesla Charging

Participants’ devices were monitored for electromagnetic interference while they sat in or stood near a Tesla S P90D.  Testing was done with the study participants situated in a variety of positions—sitting in the driver’s seat, passenger seat, backseat and standing next to the charging port.

The study found that sitting in, or standing close to the charging port of a Tesla while the car was charging at a 220 volt charging station did not trigger an ICD shock or cause interference with the assorted implantable defibrillators. 

2013 Mayo Clinic Study – Toyota Prius

Lastly, Mayo Clinic cardiologists presented similar findings at the American College of Cardiology meeting in 2013.

56050078 - gray toyota prius hybrid - sideviewThat early study found no issues when patients implanted with ICDs and/or pacemakers drove a 2012 Toyota Prius hybrid at 30 mph, 60 mph and at variable speeds of acceleration and deceleration, as well as sitting in the driver’s seat, the front passenger seat, the left and right rear seats and in front of and behind the car from the outside.  Although the researchers found that the implantable devices were exposed to electromagnetic fields inside the car, the amount of interference wasn’t significant enough to cause problems with the devices.

For more on the 2013 Mayo study, see this article in Popular Science.

 

Now that I know that driving these cars is safe for me, I will be out on a test drive trying to narrow down my options!

Chapter 4: MRI Safety for ICD & Pacemaker Patients

Yet another study has confirmed the safety of MRIs in patients with non-MRI conditional ICDs and pacemakers.

The latest study, from the University of Pennsylvania and published in the New England Journal of Medicine, found no adverse effects from 1.5 Tesla MRI scans performed on 1509 patients who underwent a total of 2103 scans.  58% had pacemakers and 42% had ICDs.

This study confirms previous findings relating to the safety of MRIs in ICD and pacemaker patients reported by HCMBeat here and here.

You can also read my personal experience trying to get a brain MRI in Los Angeles last year here.