Healthy Skepticism Library item: 17936

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Publication type: Electronic Source

Morrison T
AstraZeneca Learns the FDA May Have Gotten Wise to Copy-Cat Drugs
BNet 2010 Jun 4
http://industry.bnet.com/pharma/10008420/astrazeneca-learns-the-fda-may-have-gotten-wise-to-copy-cat-drugs/

Full text:

Could it be that the FDA is throwing up some roadblocks against the ever-popular pharma business strategy of taking a drug that is about to go off-patent, tweaking it a bit, and selling it as a new product with a new, high price tag?

Pharma has been making big bucks off the “everything old is new again” approach for decades. Case in point is AstraZeneca’s (AZN) ulcer drug Nexium (esomeprazole), which hit the market just as blockbuster Prilosec (omeprazole) went off patent. But that’s just one example. There are many others, including asthma drugs Claritin (loratadine) and Clarinex (desloratidine), antidepressants Effexor (venlafaxine) and Pristiq (desvenlafaxine), and pain drugs Neurontin (gabapentin) and Lyrica (pregabalin).

The trouble is, it isn’t always clear that the new version of the drug is any better than the old version. And sometimes, it might be worse.

That’s the problem AstraZeneca ran into this week during an FDA expert panel review of respiratory syncytial virus drug Rezield (motavizumab), a follow-on version to blockbuster Synagis (palivizumab), which goes off patent in 2015.

Panel members voted 14 to 3 that the new drug’s risks outweigh its benefits, mainly because of allergic reactions not seen with the old drug. According to BioWorld Today, one panelist said:

Motavizumab does have an effect, but no one can say at this time that it is more effective than palivizumab.

Although AstraZeneca did run head-to-head trials between the two drugs, panelists questioned some of the analyses. And an ongoing lawsuit by an employee who claims he was terminated for looking into problems with the data probably didn’t help matters.

It will be interesting to see if the FDA follows its advisory committee’s advice when it makes its ruling on motavizumab’s approvability later this month. Last week, the agency issued a complete response letter for another of AstraZeneca’s Nexium follow-on drugs. Could change be in the wind?