Novartis muscle drug granted ‘breakthrough’ FDA status
pharmafile | August 21, 2013 | News story | Research and Development, Sales and Marketing | FDA, Novartis, bimagrumab, breakthrough status, sIBM
Novartis’ new treatment for muscular degeneration has received ‘breakthrough therapy designation’ in the US, accelerating its development.
The treatment, BYM338 (bimagrumab), is an antibody designed to combat the muscle loss and weakness that accompanies sporadic inclusion body myositis (sIBM).
The condition is a rare and potentially life-threatening disease for which no effective treatment exists. Patients with the disease gradually loose the ability to walk, and can experience diminished hand function and swallowing difficulties.
Data from a Phase II study submitted to the FDA showed that BYM338 significantly benefitted patients with the condition. On the basis of those results, the regulatory body granted its breakthrough therapy designation.
This classification was designed to speed up the development of new drugs for serious, life-threatening conditions. Designated projects also benefit from greater contact with and guidance from the FDA throughout their development.
BYM338 is Novartis’ third product this year to be granted the status, after heart failure drug RLX030 and lung cancer treatment LDK378.
The Swiss’s multinational’s global head of development Timothy Wright, said: “With no effective therapies currently available for sIBM, bimagrumab has the potential to be the first real option for patients with this condition.”
Although a drug designed to treat a relatively uncommon disease is unlikely to swell the coffers at Novartis, BYM338 is also in clinical development to treat a range of conditions, including COPD, which could prove considerably more lucrative.
An estimated 64 million people had COPD globally in 2004, according to the World Health Organization, and it is one of the world’s top five leading causes of death.
BYM338 is administered intravenously and works by preventing natural ligands, such as myostatin and activin, binding to type II activin receptors, and by stimulating muscle growth.
The antibody was developed by Novartis in collaboration with German biotech company MorphoSys. The two have worked closely together on a number of projects since 2004.
Results from the Phase II study are expected to be published in a peer-reviewed journal later this year.
Hugh McCafferty
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