Janssen submits diabetes combination
pharmafile | March 12, 2013 | News story | Sales and Marketing |Â Â Janssen, diabetesÂ
Janssen has submitted a combination of its investigational diabetes drug canagliflozin with immediate-release metformin to the European Medicines Agency.
The manufacturer, which made a similar submission to the FDA in December, says this could be convenient for type II diabetes patients who may benefit from two different medications working in one pill.
Canagliflozin is in the new class of diabetes treatments called selective sodium glucose co-transporter 2 (SGLT2) inhibitors, blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels.
Metformin can be used alone or with other treatments, including insulin, in this indication and lowers blood glucose levels by decreasing the amount of glucose made by the liver and delaying intestinal glucose absorption.
Canagliflozin on its own was submitted to the European regulator in June last year and to the US authorities in May.
In January this year an FDA advisory panel recommended canagliflozin for approval, voting 10-5 in favour: if approved, it will be marketed under the brand name Invokana.
Analysts predict Invokana’s peak sales could reach $1 billion, but competition from its class rival – Bristol-Myers Squibb/AstraZeneca’s Forxiga (dapagliflozin), which gained European approval in November – will be fierce.
However, Forxiga was rejected by the same FDA committee as gave canagliflozin the nod because of suspected raised risk of breast and bladder cancer.
Janssen says it is ‘confident’ in the canagliflozin Phase III programme which included CANVAS, a study in patients who have – or are at high risk for developing – cardiovascular disease.
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.
There were also far fewer hypoglycaemia episodes compared to the old drugs, with canagliflozin also increasing HDL (‘good’) cholesterol levels – although it also raises levels of ‘bad cholesterol’ LDL.
SGLT2 inhibitors increase levels of glucose in urine too, thus raising the risk of genital mycotic infections and urinary tract infections – although Janssen says that for its drug this can be managed.
Adam Hill
Related Content
MetP Pharma releases positive data on intranasal semaglutide administration
MetP Pharma has released new data highlighting the advantages of its MetP technology in delivering …
AOTI diabetic foot care therapy to be used by NHS
Effective from September 2025, AOTI’s Topical Wound Oxygen (TWO2) therapy has been awarded inclusion in …
Recce Pharmaceuticals reports positive phase 2 data for skin infection drug
Recce Pharmaceuticals have announced positive patient data from its phase 2 clinical trial into RECCE …
