February 7, 2024

Type IB variation process finalized – original indication remains with peripheral administration included

Oncopeptides recently received a favorable opinion from the European Medicines Agency (EMA) to revert back to the originally approved indication for Pepaxti. This means that the previously communicated decision to opt out of the process to extend the indication has now been fully realized. The Product Information is reverted to the text prior the application for an extended indication for Pepaxti into earlier lines with the exception of including information regarding peripheral administration. The information regarding peripheral administration was not removed from the Product Information and is still approved as a method of administration.

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What is this?

As Oncopeptides communicated on September 28, the company has decided to not extend its indication for Pepaxti into earlier lines of treatment. Despite the company not having an intention to expand the indication, the European Commission approved the application to do so. To address this, Oncopeptides in December submitted a so called type IB-variation to remove the new indication from the product information, ultimately leading to the same intended outcome. This process has now been finalized, with the added benefit that peripheral administration is a method of administration in the officially approved conditions of use a medicine, a feature sought after by doctors in Germany.