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Top news of the day from across the health care landscape.
Officials with the FDA have raised safety concerns over an experimental rheumatoid arthritis drug developed by Eli Lilly and Co and Incyte Corp, Reuters reported. According to the article, FDA staffers said that the drug, baricitinib, poses serious risks of deadly blood clots at higher doses, a risk that had not be observed in other therapies. Reuters reported that the safety data submitted by the manufacturer raised questions as to whether the higher 4 mg dose provides additional benefits.
An expert panel on Thursday unanimously recommended that the FDA approve a new marijuana-based drug for 2 rare forms of epilepsy, STAT reported. According to the article, Epidiolex’s manufacturer, GW Pharmaceuticals, is seeking its approval to treat Lennox-Gastaut and Dravet syndromes. The FDA advisory committee voted 13-0 to recommend the drug for approval and the agency is expected to announce its decision by the end of June, the article noted.
A US study indicates that improving overall heart health may reduce the risk of atrial fibrillation, Reuters reported. According to Reuters, the tool in the study awarded 1 point for performing well with regards to each of the 7 modifiable risk factors for heart disease. The study followed middle-aged men and women for approximately 25 years and found that those who stuck most closely to a list of 7 heart-healthy practices were more than 60% less likely to develop atrial fibrillation, according to the article.
FDA Grants Accelerated Approval to Asciminib for Adult Patients With Newly Diagnosed Ph+ CML-CP