AstraZeneca abandons diabetes drug over safety concerns
pharmafile | May 5, 2006 | News story | Research and Development | AstraZeneca, PPAR agonist
AstraZeneca is to abandon its late-stage diabetes drug Galida after new results raised doubts about its safety.
Galida is a PPAR agonist – a class, which has produced two successful blockbusters, GSK’s Avandia and Takeda’s Actos. But an even greater number of candidates have failed because of safety concerns.
In 2004, an FDA request for a regulatory review into the safety and toxicology of all PPAR agonists sent Galida back into phase II studies, but it returned to phase III with apparently no major safety concerns.
Now AstraZeneca has announced new findings, which finally spell the end for Galida, with data showing the drug impairs kidney function.
The data showed elevations in serum creatinine and an associated decrease in Glomerular Filtration Rate (GFR), the most reliable indicators of compromised kidney function.
AstraZeneca says the creatinine elevation was ‘greater than anticipated based on earlier clinical studies’ but stressed that levels fell again after patients stopped taking the drug, and has not been linked with kidney toxicity.
Nevertheless, the doubts have been sufficient for AstraZeneca to pull the plug on Galida, the company conceding the new data left its risk/benefit profile unfavourable, particularly in light of other options in diabetes treatment.
AstraZeneca’s chief executive David Brennan said: “We have acknowledged that Galida was in a class with a high degree of uncertainty and the decision to discontinue is disappointing.
“We remain committed to further strengthening AstraZeneca’s pipeline of new medicines both from our own research efforts and through the continued pursuit of external opportunities to enhance our business.”
The company has other PPAR agonist programmes in development, and has indicated that lessons from Galida may mean some or all of theses drugs are abandoned as well.
Galida’s withdrawal is yet another serious blow to the company’s late-stage pipeline, which analysts say is now looking thin.
In February this year the company finally cancelled development of its first-in-class blood-thinning drug Exanta following its rejection by the FDA in 2004.
AstraZeneca has responded to pipeline concerns by increasing its in-licensing efforts, but investors say the company has yet to acquire any potentially top-earning compounds.
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