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FDA approves J&J’s diabetes combo

Invokamet combines Invokana and metformin to help reduce blood sugar
FDA headquarters White Oak

Johnson & Johnson last week became the first company to win US approval for a type 2 diabetes treatment that combines metformin with an SGLT-2 inhibitor.

Invokamet is a twice-daily single table that includes both J&J's Invokana (canagliflozin) – the first SGLT-2 inhibitor available in the US - and the standard type 2 diabetes therapy metformin.

The two drugs complement each other as canagliflozin helps the body to lose excess glucose through urine, while metformin decreases the production of glucose in the liver and improves the body's response to insulin.

Invokamet is the first combination of this kind to win FDA approval, putting it ahead of competition from AstraZeneca (AZ) and Xigduo, which combines its SGLT-2 inhibitor Forxiga (dapagliflozin) and metformin, while Boehringer and Lilly have a combination product in development involving its recently-approved Jardiance (empagliflozin).

These companies are keen to maximise the potential of SGLT-2 inhibitors, which have emerged as a promising new class of diabetes treatment since hitting the market in the past couple of years, partly due to their low risk of hypoglycaemia and ability to be used alongside other diabetes drugs.

J&J demonstrated the effectiveness of Invokamet in phase III clinical trials involving nearly 5,000 patients. These studies showed that the combination of Invokana and metformin lowered blood sugar and was associated with significant reductions in body weight and systolic blood pressure.

The FDA approval follows the decision by the European Commission in April this year to approval a combination of canagliflozin and metformin under the name Vokanamet.

This drug was the second SGLT-2/metformin combination to hit the market in Europe, with AZ winning approval for Xigduo in January 2014.

AZ also has plans to file a combination of its SLGT-2 inhibitor dapagliflozin with the DPP-4 inhibitor Onglyza (saxagliptin) potentially creating a new combination class of type 2 diabetes therapy.

Article by
Thomas Meek

11th August 2014

From: Sales

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