Novartis’ Bimagrumab Awarded Breakthrough Status
US regulators have granted Novartis’ experimental muscle wasting drug, bimagrumab, ‘breakthrough’ status, potentially granting it fast-track to being approved.
The US Food and Drug Administration (FDA) has decided to grant BYM338 (bimagrumab) a potential breakthrough because, if it is approved, it could become the first treatment for patients with sporadic inclusion body myositis, a rare but possibly life-threatening muscle-wasting condition.
sIBM (sporadic inclusion body myositis) is the most common degenerative disease of muscle in adults over 65 years old, and is characterised by a slowly progressive, asymmetric, atrophy and weakness of muscles, which often leaves patients wheelchair bound within 10 to 15 years of onset.
The decision to grant BYM338 as a breakthrough therapy was as a result of a Phase II proof-of-concept study which it demonstrated that the drug “substantially benefited” patients with the condition in comparison to placebo, Novartis noted.
“With no effective therapies currently available for sIBM, bimagrumab has the potential to be the first real option for patients with this condition,” added Timothy Wright, Global Head of Development at Novartis.