The FDA panel has taken a stand on DPP-4 inhibitors, which includes AstraZeneca’s Onglyza (saxagliptin) and Takeda’s Nesina (alogliptin), can be associated with increased risk of cardiac failure.
Way back in 2008, FDA had issued guidelines which required the makers of diabetes drugs to show that their drugs do not augment the risk of cardiovascular failure. When the FDA’s advisory panel took up the issue of Onglyza and Nesina, they could not find any increase in the risk of CVVD death, stroke, or heart attack. However there was a statistically considerable increase in the risk of heart failure associated with Onglyza, as well as an increase in all-cause mortality which worried the FDA staff.
Insulin is produced in the body after ingestion of food by incretin which has a big role to play in glycemic control. DPP-4 is the enzyme that removes incretin from the body and thus enhances glycemic control. Dipeptidyl peptidase-4 (DPP-4) inhibitors play a very crucial role in treating diabetes. An added benefit with Dipeptidyl peptidase-4 (DPP-4) inhibitors is that it is not associated with hypoglycemia or weight gain.
However it must be noted that increased risk of cardiac failure could be a DPP-4 class effect. Therefore in spite of a new warning label regarding heart risks being possible, the product uptake won’t be affected and the panel did not recommend new restrictions on prescriptions.
It will be a big relief to AstraZeneca because some analysts had predicted its number one anti diabetic drug, Onglyza could see its sales fall by as much as 50%.
Leerink analyst Seamus Fernandez in a research note reported by Reuters said, “Given the absence of a serious safety issue for either Onglyza or Takeda’s Nesina suggests that, barring an overtly negative signal in TECOS, growth of the DPP-4 class is likely to continue without a meaningful change in current prescribing trends.”
The advice of the advisory panels is not obligatory but the FDA often follows its advice.