US FDA warns of stroke risk with multiple sclerosis drug: industry news round-up

Written by Sharon Salt, Editor

In this week’s industry news round-up we cover the latest headlines on the clearance of gammaCore™ for cluster headache, warnings of stroke risk with a multiple sclerosis drug and an investigational gene therapy for spinal muscular atrophy. Find out more about our selection of the highlights below.
Our selection of the highlights includes:

gammaCore™ receives clearance for the preventive treatment of cluster headache

electroCore (NJ, USA) has announced that it has received clearance from the US FDA for an expanded label for gammaCore™ therapy, a non-invasive vagus nerve stimulator (nVNS), for the adjunctive use for the preventive treatment of cluster headache in adult patients.

Currently, there are no FDA-approved pharmacologic treatments for the prevention of cluster headache and this milestone marks the first and only product that has been FDA cleared for this condition.

“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as ‘suicide headache’,” commented Frank Amato, Chief Executive Officer at electroCore.

The clearance was supported by results from two studies, including the PREVA pivotal study, which demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of cluster headache. The second study reviewed by the FDA was a real-world retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of cluster headache.

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US FDA warns of stroke risk with multiple sclerosis drug

The FDA has warned that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS), shortly after they received Lemtrada® (alemtuzumab).

Since the FDA approved Lemtrada in 2014 to treat relapsing forms of MS, they have identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patients received the drug. This number includes only reports submitted to the FDA, thus additional cases they are unaware of may have occurred.

Twelve of these cases were reported to have symptoms within 1 day of receiving Lemtrada. As a results, the FDA has included a new warning about this risk in the prescribing information in the drug label and have added the risk of stroke to the existing Boxed Warning – the FDA’s most prominent warning.

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Investigational gene therapy (Zolgensma®) gains BLA acceptance for spinal muscular atrophy

Novartis (Basel, Switzerland) has announced that the FDA has accepted the company’s Biologics License Application (BLA) for AVXS-101, now known as Zolgensma® (onasemnogene abeparvovec-xxxx). Zolgensma is an investigational gene replacement therapy for the treatment of spinal muscular atrophy Type 1 and is designed to address the genetic root cause of the disease.

Previously, Zolgensma received a Breakthrough Therapy Designation and has been granted Priority Review by the FDA, with regulatory action anticipated in May 2019.

“The introduction of one-time, potentially curative therapies will require rethinking how our healthcare system manages diagnosis, treatment, care and associated costs for patients with genetic disease. Novartis and AveXis are proud to lead the way toward a modern healthcare system built on the tremendous value of truly innovative and transformative medicines that could bend the curve of life,” concluded David Lennon, President of AveXis (IL, USA).

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