J&J's long-lasting diabetes combo approved in US

The US Food and Drug Administration has approved Johnson & Johnson’s extended release diabetes drug, Invokamet XR (canagliflozin+metformin), giving the firm a boost as it prepares for near-copy competition to its key biological drug, Remicade.

Invokamet XR is indicated in first line as an adjunct to diet and exercise, to improve blood glucose control in adults within type 2 diabetes, when treatment with the two medications is appropriate.

The drug combines Invokana, J&J’s most-prescribed sodium glucose co-transporter (SGLT2) inhibitor, and an extended release formulation of the commonly prescribed diabetes drug, metformin.

Invokamet XR is available in four doses – in tablets containing canagliflozin 50mg or 150mg, and metformin XR 500mg or 1,000mg.

Recommended dose is two tablets once daily with the morning meal, and there is also a boxed warning for lactic acidosis, a rare but serious complication that can occur to metformin accumulation.

Already approved in immediate release form in the US and EU, the drug is becoming increasingly important to J&J, pulling in sales of $383 million in Q2, a 20.4% increase on the same period last year.

The Invokana products lead the SGLT2 market currently, with Lilly and Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga/Forxiga trailing behind it.

However Jardiance has gained an important advantage, as it on the verge of gaining FDA approval to claim cardiovascular benefits, based on its EMPA-REG trial.

J&J is conducting its own long-term cardiovascular outcomes CANVAS trial for Invokana, but this won't report until 2017.  The trial has run into trouble, however, with signs that patients may have a higher risk of lower limb amputations.

Newer products will be key to the success of J&J’s pharma business, as it braces itself for biosimilar competition to its Remicade (infliximab) in the US.

Remicade pulled in sales of $1.8 billion in Q2 alone, based mostly in the US as biosimilars are now well established in the EU.

J&J expects Pfizer’s near copy of infliximab, developed by South Korea’s Celltrion, to be launched in early October.

Although J&J said it will “vigorously defend” its patent on Remicade, the drug is nearing the end of its patent life and J&J will look to new products such as Invokamet to make up for the lost sales.