Breakthrough therapy designation by FDA for Novartis treatment

Novartis today announced that the US Food and Drug Administration (FDA) has granted BYM338 with breakthrough therapy designation to for sporadic inclusion body myositis (sIBM).

The FDA created breakthrough therapy designation in order to expedite the development and review of new drugs for serious or life-threatening conditions.

BYM338 was granted breakthrough therapy designation based on the results of a Phase II proof-of-concept study showing that it substantially benefited patients with sIBM compared with placebo.


“BYM338 is the third example this year of Novartis’ leadership in bringing breakthrough therapies to patients reinforcing our commitment to innovation addressing significant unmet medical needs and enhancing the lives of patients,”
Timothy Wright, M.D., Global Head of Development, Novartis Pharmaceuticals.

If BYM338 is approved, it has the potential to be the first treatment for sIBM patients.


Reference links:

Novartis press release

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