Tuesday, July 9, 2013

Aleglitazar Phase 3 trial halted due to safety signals - Implications for Cadila's Lipaglyn

The Independent data and safety monitoring board has recommended to halt the AleCardio trial  evaluating the safety and efficacy of Aleglitazar ( dual PPAR agonist) in patients with recent ACS and type 2 diabetes. This is yet another failure in the dual PPAR agonist space.

Table 1
DISCONTINUE DUAL PPAR AGONISTS
Discontinued Compounds

Phase of Development When discontinued
Safety Issue
Muraglitazar
Brisol-Myers
Phase 3
Edema, Heart Failure, Weight Gain
Tesaglitazar
AstraZeneca
Phase 3
Elevation in Serum Creatinine / decline in Glomerular filtration rate
Ragaglitazar
Novo Nordisk / Dr. Reddy
Phase 3
Bladder tumors
JTT-501
Japan Tobaco

Edema
Farglitazar

GlaxoSmithKline
Phase 3
Edema and lack of efficacy
Imigltiazar

Takeda Phama
 Phase 3
Abnormalities in Liver Enzyme

We see this news to have implications for Cadila's Lipaglyn, which is the only dual PPAR agonist, to have been approved by a drug regulator anywhere in the world. Recently the Indian drug regulator has given a nod for aprpoval to Lipaglyn. Since the clinical data is not disclosed , whether or not Cadila has done adequate safety evaluation (CV and safety) in a reasonable population remains unknown. 

The Indian drug regulator - DCGI which has recently banned pioglitazone for marketing in India,  would be in a fix and wondering whether they have done the required level of evaluation before granting the approval to Lipaglyn

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