FDA Grants Novartis Biologic Breakthrough Status
Novartis’ fully human monoclonal antibody bimagrumab (BYM338), intended to be a treatment for sporadic inclusion body myositis (sIBM), was granted breakthrough designation by the US Food and Drug Administration (FDA) this week.
Such designation is intended to expedite the development and review of drugs that treat serious or life-threatening conditions and is subject to several fast-track features as well as more intensive FDA interaction and guidance.
Novartis spokesperson Anja von Treskow told Biopharma-Reporter.com for a biologic “the program requires more lead time for technical development and particularly scale up” than for a small molecule.
Bimagrumab’s designation is a distinct status from both accelerated approval and priority review and thus we asked von Treskow if there are any issues in standards and safety due to the expedited nature of the development programme.
“FDA’s quality standards for a novel biopharmaceuticals are high, and we do not cut corners neither in development nor manufacturing when going fast,” she told us. “FDA would not permit a biologic to become commercial that did not meet its stringent standards.”
The muscle wasting therapy was developed by Novartis from an antibody identified from Morphosys’ HuCal library, and works by stimulating muscle growth, blocking signalling from inhibitory molecules by binding with high affinity to type II activin receptors.
The drug is still in development and was granted the designation following results of a Phase II proof-of-concept study showing it to be beneficial when compared to placebo.
This is Novartis’ third biopharmaceutical to receive breakthrough status this year, following serelaxin (RLX030) for acute heart failure and LDK378, an investigational selective inhibitor of ALK[1], a target found in a variety of cancers.
