27 November 2009

Antibiotics - the EU pipeline is empty too

We've talked before about the shrinking number of drugs available to treat MRSA and about the challenges of getting new drugs to market. Well, it's not just a problem in the United States.

A new report from the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) — that's the CDC and the FDA of the European Union — analyzes the bench-to-market "pipeline" of new drug development in the EU and finds... not good news. Out of 167 antibacterial agents that are somewhere in the pipeline of development, only 15 look likely to improve treatment of resistant organisms over drugs that already exist — and 10 of those 15 are in early-stage trials and will not come to market anytime soon.

That leaves 5 potential new drugs, for an epidemic of antibiotic resistance that, just in the EU, causes 25,000 deaths and $1.5 billion Euros ($2.27 billion) in extra healthcare spending each year.

(Within that epidemic of resistance, by the way, the single most common organism is MRSA.)

It's worth understanding how the agencies conducted their analysis. When we look for new drugs to treat resistant organisms, we ideally need several things:
  • a formula or molecule that is new (and not just an improved version of an existing one, because if bacteria have developed resistance against the existing one, they have a head start in developing resistance against the new one)
  • a new mechanism or target on the bacterial cell, and not an improved version of an existing one (ditto)
  • evidence that it works in living organisms, and not just in lab dishes (in vivo, not just in vitro)
  • evidence that it can be given internally, not just topically (necessary for addressing the most serious infections)
  • and some indication that it is making its way through the regulatory approval process in time to achieve some practical good.
Here's what the EU pipeline looks like:
  • 167 agents in process
  • 90 that have shown effectiveness in vivo
  • 66 that are new substances
  • 27 that have a new target or mechanism
  • 15 that can be administered systemically
If you're wondering whether you should be depressed, the answer is Yes.
... it is unclear if any of these identified agents will ever reach the market, and if they do, they may be indicated for use in a very limited range of infections.
The agencies call for a concerted government effort to turn this around, and ask for quick action because it takes years to get drugs through the pipeline:
...a European and global strategy to address this serious problem is urgently needed, and measures that spur new antibacterial drug development need to be put in place.
This echoes a call that has already been made in this country by the Infectious Diseases Society of America, which has asked for changes in incentives to drug-makers, and has backed what's known as the STAAR Act (STrategies to Address Antimicrobial Resistance). With this latest EU report — which comes on the heels of a US-ER agreement to work cooperatively on resistance — the IDSA is asking for an international commitment to bringing forth 10 new drugs in 10 years, what they are calling 10 x '20.


Anonymous said...

There is lots of anti-MRSA treatments on the way it is Gram-negatives where there is a problem.

Maryn McKenna said...

Yes, both this EU report and IDSA's ESKAPE report from early this year address this: The need for drugs against the resistant Gram-negatives is critical. I don't agree though that the Gram-positives (MRSA included) are taken care of; just look at the difficulties that dalbavancin, ceftobiprole and oritavancin faced or continue to face in getting to market, as well as increasing reports of resistance to daptomycin and linezolid.