US drops Novo Nordisk insulin

Danish pharmaceuticals giant Novo Nordisk announced to the stock exchange on Sunday night that it has to accept the American Food and Drug Administration’s (FDA) decision to demand further testing of two of the company’s insulin products, Tresiba and Ryzodeg.

In a so-called Complete Response Letter, the FDA writes that the application to register the two products cannot be approved in its current form, which causes quite a setback for Novo Nordisk.

Disappointed

Due to its size, the American market is very important to the Danish pharmaceutical corporation, and the two third-generation products were supposed to earn a large share of the company’s future profits on the American market.

Now, however, more testing is in store before the insulin can make it into American drugstores.

“We were disappointed and surprised to receive such a response, but we abide by the FDA’s decision and plan to co-operate with the authorities in order to find the best way of completing our registration applications,” said CEO Lars Rebien Sørensen.

“We’re convinced Tresiba and Ryzodeg will make a significant difference for people who need insulin treatments,” said Sørensen in the announcement on Sunday.

Approved by the EU

Novo Nordisk does not expect the FDA testing to be completed during 2013.

In January, the Tresiba and Ryzodeg products were approved by the European Commission, and they are also cleared for sale in Japan.

The rejection by American health authorities will not make a significant impact on the 2013 accounts