Swiss drug maker Novartis AG (NVS) said the US Food and Drug Administration or FDA has granted breakthrough therapy designation to BYM338 for sporadic inclusion body myositis or sIBM, which is a rare yet potentially life-threatening muscle-wasting condition.
"BYM338 is the third example this year of Novartis' leadership in bringingbreakthrough therapies to patients reinforcing our commitment to innovationaddressing significant unmet medical needs and enhancing the lives of patients," said Timothy Wright, M.D., Global Head of Development, Novartis Pharmaceuticals.
The FDA has created Breakthrough therapy designation to expedite the development and review of new drugs for serious or life-threatening conditions. This designation is based on the results of a Phase II proof-of-concept trial that demonstrated BYM338 substantially benefited patients with sIBM compared to placebo. The study results would be presented at the American Neurological Association meeting on October 14 and is likely to be published in a major medical journal later this year.
BYM338 or bimagrumab, a novel, fully human monoclonal antibody developed to treat pathological muscle loss and weakness, was also granted orphan drug designation in sIBM in both the U.S. and Europe in 2012.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.