FDA approves Novo Nordisk growth hormone treatment

The US Food and Drug Administration (FDA) has approved Norditropin FlexPro.

The US FDA has approved Norditropin FlexoPro

The US Food and Drug Administration (FDA) has approved Norditropin FlexPro, a prefilled growth hormone injection pen to be used by children and adults.

The device, from Danish firm Novo Nordisk, has a new dosing mechanism and user-friendly design, which makes it easy to learn and use. An audible click confirms that the dose has been delivered. No reconstitution or loading of cartridges is necessary.

Norditropin FlexPro is available in 5mg/1.5ml, 10mg/1.5ml and 15mg/1.5ml pens.

In a handling study, 100% of patients found it easy to learn how to use the device, 99% reported that it was easy to push the button to dose, and 97% felt confident that the correct dose was delivered.

"We are convinced that daily injections will be made even simpler, so patients are better able to achieve their individual treatment goals," said Pablo de Mora, global vice president of Growth Hormone Treatment at Novo Nordisk.

Novo Nordisk introduced Norditropin in 1988; the first liquid growth hormone formulation, Norditropin SimpleXx, in 1999; and the first prefilled growth hormone pen, Norditropin NordiFlex, in 2004. Norditropin FlexPro is the latest advance in growth hormone pens building on this heritage.

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Novo Nordisk Pharmatech (more information, website)