FDA Delays Ofatumumab Decision, Yoga Improves Migraine, Ticagrelor Gains FDA Approval


Neurology News Network for the week ending June 6, 2020.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Novartis recently announced that the FDA has delayed its regulatory decision on ofatumumab, originally expected sometime this month, to September 2020. It’s not clear why the agency pushed back the decision date, though some have speculated that the ongoing delays associated with the coronavirus disease 2019 pandemic may have contributed. Marie-France Tschudin, president of Novartis, in a statement said, “We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.” The fully human anti-CD20 monoclonal antibody is already approved in the US and Europe as first-line treatment for chronic lymphocytic leukemia and recurring CLL. It is marketed under the name Arzerra.

Findings from the CONTAIN study suggest that yoga, when utilized as add-on therapy, has a superior impact for patients with migraine compared to medical therapy alone. The study authors noted this suggests that integrating a cost-effective and safe intervention such as yoga into the management of migraine would be beneficial. Data showed that compared with medical therapy alone, at 3 months, the yoga group showed a significant mean delta value reduction in headache frequency, headache intensity, Headache Impact Test score, and Migraine Disability Assessment score. Additionally, those in the yoga group had a significantly lower rescue pill count amount compared to those in the medical care group.

The FDA has approved ticagrelor for the reduction of risk for first heart attack or stroke in patients with coronary artery disease. This is the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in those who are high-risk but have no history of heart attack or stroke. Deepak Bhatt, THEMIS trial Co-Chair and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital said in a statement, “Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people. The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.” Label information for ticagrelor highlights an increased bleeding risk, similar to other antiplatelet agents, that can result in significant and sometimes fatal bleeding. Ticagrelor is also contraindicated in those with active pathological bleeding or history of intracranial hemorrhage.

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