Date: 2013-08-20
Type of information: Granting of the Breakthrough Therapy status
Product name: BYM338
Compound: bimagrumab (recombinant human monoclonal antibody against activin receptor type IIB)
Therapeutic area:
Action mechanism: BYM338 (bimagrumab) is a novel, fully human monoclonal antibody developed to treat pathological muscle loss and weakness. BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody. BYM338 binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. BYM338 stimulates muscle growth by blocking signaling from these inhibitory molecules. In addition to being developed for sIBM, BYM338 is in clinical development for chronic obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia and in mechanically ventilated patients. BYM338 is administered by intravenous infusion.
Company: Novartis (Switzerland)
Disease: sporadic inclusion body myositis (sIBM)
Latest news: * On August 20, 2013, Novartis has announced that the FDA has granted breakthrough therapy designation to BYM338 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 BYM338 substantially benefited patients with sIBM compared to placebo. The results of this study will be presented at the American Neurological Association meeting on October 14 and is expected to be published in a major medical journal later this year.
* On July 11 2012, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending recombinant human monoclonal antibody against activin receptor type IIB for designation as an orphan medicinal product for the treatment of inclusion body myositis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2012-08-09
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
