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Janssen’s diabetes drug Invokana recommended

Published on 11/01/13 at 01:29pm
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An FDA advisory committee has recommended Janssen’s new diabetes treatment canagliflozin for approval.

To be marketed under the name Invokana, canagliflozin is in the new class of diabetes treatments called selective sodium glucose co-transporter 2 (SGLT2) inhibitors.

Its rival in the class is Bristol-Myers Squibb/AstraZeneca’s Forxiga (dapagliflozin). Forxiga gained European approval in November, but was rejected by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee earlier in the year because of suspected raised risk of breast and bladder cancer.

The same FDA committee has now voted 10-5 in favour of canagliflozin, indicating their greater confidence in its safety and efficacy compared to its rival.

The drugs are once-daily pills and could play a significant part in advancing treatment of type II diabetes. Analysts predict Invokana’s peak sales could breach the $1 billion mark, but competition in the field will be fierce.

Two head-to-head studies comparing canagliflozin to Merck’s blockbuster Januvia and older sulfonylurea treatment glimpiride, showed the new drug provided significantly greater reductions in A1C levels, fasting plasma glucose levels, body weight, and systolic blood pressure.

Moreover, there were also far fewer hypoglycaemia episodes compared to the old drugs. Invokana also increased HDL (‘good’) cholesterol levels, however, it also levels of ‘bad cholesterol’ LDL.

SGLT2 inhibitors block the reabsorption of glucose by the kidney, increasing glucose excretion, thereby lowering blood glucose levels.

The kidneys of people with type II diabetes reabsorb greater amounts of glucose than normal, which may contribute to elevated glucose levels. By blocking reabsorption of glucose by the kidney, SGL2 drugs increase glucose excretion, and lower blood glucose levels.

However, because the drugs increase levels of glucose in urine, they also raise the risk of genital mycotic infections and urinary tract infections. Nevertheless, Janssen says for its drug, these can be managed and can be well managed by the doctor, and in some cases, the patient themselves.

Some members of the FDA advisory committee also raised concerns about using the drug in patients with moderate renal impairment. The FDA’s final decision, and the wording of its licence will therefore have a big influence on the drug’s commercial potential. 

The drug’s Phase III data which enrolled 10,285 patients in nine studies, included three large studies in special populations: older patients, patients with moderate renal impairment, and patients who had or were at risk for cardiovascular disease.

Janssen acquired marketing rights for the drug from Japanese company Mitsubishi Tanabe, which has retained the rights for some markets in Asia.

Andrew McConaghie

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