AIFA's stop to growth hormone

A serious shortage of the medicine had already been reported since April 2023 based on somatropin Norditropin NordiFlex 15mg/1.5ml solution for injection, produced by Novo Nordisk, as communicated by AIFA. The situation has worsened with new news: the definitive suspension of the sale of this medicine, in all its authorized versions.

The Italian Medicines Agency has decided to stop marketing the drug produced by Novo Nordisk. As the company itself specifies to QuiFinanza, this means that it will no longer be available for sale, due to lack of the product itself. However, the product already available and possibly purchased by Italians remains usable.

“This is very different from withdrawal”, the pharmaceutical company specifies, “as the withdrawal of a drug is ordered only and exclusively in the event of dangers for the user. And this is absolutely not the case.”

Because the product will no longer be sold

Norditropin NordiFlex contains somatropina growth hormone used to treat various growth-related disorders in both children and adults. This disruption in its availability has made it difficult to manage patients who depend on this treatment.

The main reason for the suspension of the Norditropin NordiFlex drug is therefore to be found in the very low availability of the product, which severely affected patients, as it represented the only therapeutic option authorized in Italy for the treatment of those who have a height deficit linked to Noonan Syndrome. Therefore, there is no risk for those who continue to use the drug already purchased, because this is in no way a safety problem for the medicine.

For this very reason, AIFA has taken measures by inserting another somatropin medicine on the list of authorized substances for this indication.

The change to alternative therapies is not easy. Healthcare workers were invited in the AIFA statement to inform patients and switch to alternative therapies based on their assessment and local regulations.

Stopping treatment with Norditropin NordiFlex could pose risks to both children and adults. In children, early discontinuation could compromise the effectiveness of treatment, while in adults it can lead to complications related to health and body composition.

How much does Norditropin NordiFlex cost

The shortage of the drug was already reported last year in the USA, when the spokeswoman for Novo Nordiskthe Danish manufacturer of the drug, responded to the numerous criticisms and requests: “Unforeseen circumstances have led to longer than expected ramp-up times to expand capacity in our new production facility and meet the ever-increasing global demand for Norditropin” .

The shortage of Norditropin has created problems accessing the drug through the company's patient assistance programs, including one that provides the medicine free of charge to those who need it and meet the requirements.

Norditropin represents a significant investment: the list price for the most commonly used pen stands at $1,535.70, while a one-month supply can exceed $6,000, according to GoodRx, a website that specializes in offering drug discounts to patients. In Italy those who need it benefit from the exemption from the NHS, but the list price is around 578 eurosaccording to data from Pharmap.