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Novartis drug for muscle-wasting condition gets FDA breakthrough designation

  • Novartis (NVS +2.4%) has received FDA breakthrough therapy designation for its BYM338 (bimagrumab) drug for treating sufferers of sporadic inclusion body myositis (sIBM), a rare yet potentially fatal muscle-wasting condition.
  • If eventually authorized, BYM338 has the potential to become the first treatment for sIBM.
  • BYM338 is the third Novartis drug this year to obtain the FDA's breakthrough designation. The company developed it with Morphosys (MPSYF.PK).
  • Patients with sIBM can gradually lose their ability to walk, experience falls and injuries, lose hand function, and have swallowing difficulties. (PR)
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