Approval of Bedaquiline in the EU: Time for a regulatory rethink?

I note that yesterday J&J got a conditional approval on their tuberculoisis (TB) drug Bedaquiline. You may remember that this drug was approved by the FDA in late 2012 and represents a new treatment for multidrug resistant TB. One wonders why the EU took over a year longer, was their more concern with some of the issues around potential toxicity perhaps?

It also makes you think that here we are in the USA and EU with our regulators approving a drug that will be used elsewhere in the world? The number of MDR cases in the west is likely to be miniscule compared to Africa, India etc..I just thought I should point that out.  Does this not suggest that its time that there was a single global regulatory body that took care of drugs for diseases of this nature, why duplicate efforts between the USA and EU.

It does of course remind us that this was the first drug approved for TB in over 40 years and how long will it be before another reaches the stage that bedaquiline is at? Could we speed it up by changing the way such urgently needed drugs are approved for a global population. Well over a million people a year die from TB globally and on average we are investing about $500M in TB R&D etc which is a pittance. I humbly think its time we pulled our socks up. There are well over 1500 hits from high throughput screening between NIAID and company efforts, and they are languishing. Our R&D efforts are disjointed and clearly our regulatory organizations are not aligned even when such a molecule makes it through the clinic.

But who will fix it and get everyone on the same page?  Bedaquiline should be a wake up call for the next generation of treatments.


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