The FDA ( Food and Drug Administration ) has granted breakthrough therapy designation to Bimagrumab for sporadic inclusion body myositis ( sIBM ).

Breakthrough therapy designation was created by the FDA 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 study that showed Bimagrumab substantially benefited patients with sporadic inclusion body myositis compared to placebo.

Sporadic inclusion body myositis is a rare disease, yet it is the most common degenerative disease of muscle in adults older than 65 years. It is characterized by a slowly progressive, asymmetric, atrophy and weakness of muscles. Commonly, patients become wheelchair bound within 10 to15 years of onset. Death may occur due to injurious falls, infection ( aspiration pneumonia ), or malnutrition.

Bimagrumab is a novel, fully human monoclonal antibody developed to treat pathological muscle loss and weakness. Bimagrumab was developed by the Novartis Institutes for Biomedical Research ( NIBR ), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody.
Bimagrumab binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. Bimagrumab stimulates muscle growth by blocking signaling from these inhibitory molecules.

In addition to being developed for sporadic inclusion body myositis, Bimagrumab is in clinical development for chronic obstructive pulmonary disease ( COPD ), cancer cachexia, sarcopenia and in mechanically ventilated patients.

Bimagrumab is administered by intravenous infusion. ( Xagena )

Source: Novartis, 2013

XagenaMedicine2013