January 14, 2013

New T2D Drug: Blockbuster or Bridge to Nowhere

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pipeline_drugA new Type 2 diabetes drug is under development by Johnson & Johnson (JNJ) and if approved will be marketed as Invokana. The drug works by excreting glucose into the urine. This puts a high demand of labor on the kidneys and the FDA advisory panel expressed concerns about the risk of harm to the kidneys.

In clinical trials, the drug was shown to improve blood glucose levels as well as reducing body weight and blood pressure. It is a daily oral medication. Considering the taxes on the kidneys, doctors were concerned that patients with impaired kidney function should not use the drug.  Patients in the study found that the drug was not as effective on them as it was for those with normal kidney function. In addition, the panel felt that the drug was inappropriate for use on patients with severe kidney disease.

Risks also highlighted in the clinical trials point to systemic complications like stroke, heart attack and other cardiovascular problems within the first 30 days of treatment. Canagliflozin was found to raise LDL (“bad cholesterol”) levels; however, it also raised the levels of HDL (“good cholesterol”). Raising the good is great, but simultaneous raising the bad could be ugly.

A workaround for these concerns could suggest that JNJ include appropriate warnings on the drug, if eventually approved by the FDA. For your information, the FDA is not required to follow the recommendations of its advisory committees. But as many pharmaceutical companies have learned the expensive way, it’s cost-effective to play nice and put the critical black box warnings where needed.

One journalist who wrote on the story had a great point. He notes that if diabetes is a shortage of insulin and a surplus of glucose – why open the floodgate to let the supply of both, insulin and glucose, dwindle? It’s self-defeating to throw the baby out with the bathwater. Time will tell if this pipeline drug is a blockbuster or a bridge to nowhere.

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