Bayer recently received FDA approval for a connected auto-injector for relapsing-remitting multiple sclerosis medication and companion app. The device is called the Betaconnect Electronic Autoinjector and the app, due out in July, is myBetaApp.
The Whippany, New Jersey-based pharma company didn't clear the app and device through the 510(k) medical device pathway; instead the agency approved a supplemental Biologics License Application for the drug, Betaseron.
"On occasion, when a drug company was to get a new biological product approved, if they want a companion app, they can get that companion app approved through the same BLA," Bradley Merrill Thompson, an attorney at Epstein Becker Green, explained to MobiHealthNews in an email. "In a similar way, for drug companies to get a new drug approved, if they want a companion app, can get that app approved through a new drug application. But quite honestly no one would ever describe an NDA or BLA as a preferable regulatory pathway to the 510(k). They are both very onerous, because they are principally directed at new biological products and drugs."
The main advantage to the app and the Bluetooth connectivity is that it allows patients to automatically have a record of all their injections and share that record with their nurse or physician. A record is kept of the injection date and time, as well as speed and depth, which can be adjusted on the device.
The app can also help with medication adherence, displaying a calendar for injections and sending reminders by email, and can advise patients about where on their body to use the injector (Betaseron users often rotate injection sites). The injector also has built-in reminders.
"Since introducing the first FDA approved treatment option for relapsing remitting multiple sclerosis patients more than two decades ago, we've listened closely to the community to understand their needs and how we can support them," Mark Rametta, Bayer's medical director for Neurology, said in a statement. "The myBetaApp and Betaconnect Navigator add to the services that we've developed based on patient feedback, including 24/7 access to nurse support and the first and only electronic autoinjector for patients taking Betaseron."
The app will be available on both the iOS App Store and the Google Play Store. While it is just now coming to the US, it has been available in some other countries for a number of years -- it has been available in Germany, Switzerland, Australia, and the Netherlands since 2015. A version of the app without device connectivity actually hit the Australian app store in 2011.
Connected injectors are a relatively new space in digital health. Sanofi and Eli Lilly have both worked with startups on connected insulin pens. Quio, a New York startup that raised $1 million last year, is working on a sensor-enabled drug injector and companion software for the clinical trial and chronic disease market.