AstraZeneca Discontinues Development of GALIDA TM (tesaglitazar)
Thursday, 4 May 2006
AstraZeneca today announced the discontinuation of the GALIDA development programme. GALIDA is a dual PPAR alpha and gamma agonist and was in phase III development for the treatment of the glucose and lipid abnormalities associated with type 2 diabetes.
Following analysis and interpretation of recently obtained results from the first four of eight Phase III clinical trials (GALLANT 6,7,8 and 9) and one Phase II trial (ARMOR), which were reviewed in consultation with external experts, the company considers that the overall benefit / risk profile is unlikely to offer patients significant advantage over currently available therapy.
Central to the decision is data showing elevations in serum creatinine and an associated decrease in Glomerular Filtration Rate (GFR). The magnitude of the serum creatinine elevation was greater than anticipated based on earlier clinical studies. Such elevations reversed towards baseline upon stopping treatment with the drug and have not been associated with kidney toxicity.
There is no immediate safety concern for patients and all primary efficacy endpoints were met in the Phase III trials. Patients are advised to speak with their physician before stopping their treatment. All ongoing GALIDA clinical studies will now be brought to a close and physicians will be advised to switch patients to the alternative available therapies at their next scheduled visit. There are currently 2,245 patients taking GALIDA within clinical trials.
David Brennan, Chief Executive Officer, AstraZeneca PLC, commented: “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.”
Further analysis of data from the GALIDA development programme is ongoing and the company will make the data available as appropriate through scientific presentation, publication and via the company’s Clinical Trials Website once completed.
AstraZeneca has other PPAR agonist programmes in development and learning from the GALIDA programme will be applied to these once final analysis of the data is concluded.
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