FDA vote on J&J diabetes drug
pharmafile | January 10, 2013 | News story | Sales and Marketing |Â Â EU, FDA, J&J, JJ, Janssen, canagliflozinÂ
Key advisers to the FDA are meeting today to decide whether Janssen Pharmaceuticals’ type II diabetes drug canagliflozin is safe to market.
Points for discussion at the meeting of the Endocrinologic and Metabolic Drugs Advisory Committee will include cardiovascular safety, the risk of using canagliflozin in patients with moderate renal impairment and the incidence of bone fractures in trials.
Johnson & Johnson executives will be crossing their fingers for a vote in favour, since the US regulator is likely to follow the advice of its committee.
The drug is in a novel class of sodium glucose co-transporter (SGLT)-2 inhibitors, which also includes Bristol-Myers Squibb/AstraZeneca’s Forxiga (dapagliflozin), which gained European approval last year.
The tablets work by inhibiting the SGLT2 – a protein in the kidneys that allows glucose to be reabsorbed into the bloodstream – improving glycaemic control without increasing insulin secretion.
Its major difference from other diabetes treatments is that it works independently of insulin to help remove excess glucose from the body.
In a therapy area where there remains a high level of unmet need, canagliflozin’s novel mode of action may swing a vote in its favour: if approved, J&J will market the drug under the brand name Invokana.
The meeting today is scheduled to cover the clinical relevance of changes to blood pressure, weight and low-density cholesterol levels toward informing overall cardiovascular benefit/risk.
Committee members have been asked to think about the impact of renal function on the glucose-lowering effect of canagliflozin, the pill’s potential role in deterioration of the kidneys and an observed increased risk of genitourinary tract infection.
They will also look at an analysis of the Phase III development programme which indicates “a numerical imbalance not favouring canagliflozin” in the incidence of fractures.
However, even if the vote goes against canagliflozin, J&J may take heart from the example of Forxiga, which was itself rejected by the same FDA committee last year.
The FDA has asked for more information on Forxiga, suggesting the door is not closed.
Meanwhile, figures from the World Health Organisation suggest there are around 350 million people with diabetes, with several million a year dying worldwide from the disease.
Adam Hill
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