FDA Issues Approval For Bayer Autoinjector For Multiple Sclerosis Therapy

Bayer HealthCare announced that the U.S. Food and Drug Administration has approved the use of BETACONNECT, the first and only autoinjector for BETASERON, a prescription medication for treating relapsing-remitting multiple sclerosis (RRMS).

BETASERON was first approved by the FDA 22 years ago to treat relapsing forms of multiple sclerosis. The original device that delivered the medication had drawbacks as it is activated mechanically and produces a discernible sound when being used, which gets to some patients, explained Amy Perrin Ross, International Organization of MS Nurses' former president.

Taking note of feedback from caregivers and patients alike, Bayer created BETACONNECT, offering customizable injection depth and speed settings to let patients choose a manner of administration that will be most suitable for them. The autoinjector is quiet and precise to use, fitted as well with automatic needle insertion and retraction function and an optional back-up reminder that advises patients when their next dose is coming up. At the same time, audio and visual indicators are provided to signify that a dose has been administered.

Douglas Franklin, CEO and president of the Multiple Sclerosis Association of America, said that offering new options to patients with multiple sclerosis is crucial because there's no one-size-fits-all approach to managing the disease. Ross added that injectables are an important treatment option for RRMS and the approval of BETACONNECT by the FDA represents a major move that gives patients the power to tailor their treatment.

It is estimated that 400,000 people in the United States are living with multiple sclerosis. Out of this number, around 320,000 have been initially diagnosed to have RRMS, in which symptoms can completely or partially disappear after a flare-up and then followed by a stable period that can last for months and even years.

BETACONNECT is already available in Europe.

"We are pleased to offer the first and only electronic auto injector for those living with the disease," said Klaus Marten, vice president and Neurology general manager for Bayer.

Also sold by Bayer, BETASERON is prescribed to cut down on the number of relapses RRMS patients experience. This includes those who have MRIs consistent with multiple sclerosis and those who have had their first symptoms of the disease. After preparing BETASERON, it is to be administered using BETACONNECT, utilizing only the syringes that come with the medication.

Photo: J E Theriot | Flickr

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