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Not approved in the EU: Another setback for the drug tanezumab


The painkiller tanezumab was not approved by the European Medicine's Agency.

At the beginning of 2021, news came that tanezumab, a new pain medication, would be launched in the US and Europe. 

However, in March, tanezumab suffered a setback in the United States when the US Food and Drug Administration rejected the drug for osteoarthritis pain.

There was continued uncertainty about the launch of the drug in Europe as the European Medicines Agency (EMA) had not yet voted in favor of the approval of tanezumab.

In September, the EMA finally issued its opinion: The drug would not receive market approval in Europe either.

The argument given by the EMA was that

"although tanezumab showed better pain relief and improved physical functioning in patients with osteoarthritis affecting the hip or knee compared with placebo, the difference was small. In addition, there was no improvement in pain relief and physical functioning when compared with NSAIDs. In terms of safety, patients were at an increased risk of side effects compared with patients receiving placebo or NSAIDs."

The EMA concluded that the benefits of the drug did not outweigh its risks and therefore recommended against tanezumab's approval in Europe.

Read the whole EMA refusal here.