CHMP recommends Voraxaze to reduce toxic plasma methotrexate concentration.

The benefits of Voraxaze are a clinically important reduction in methotrexate concentration in at least 62% of treated patients with a median reduction of > 98% in methotrexate concentration occurring within 15 minutes following glucarpidase administration, as observed in four compassionate-use, open label multicentre studies. The most common side effects are burning sensation, headache, paraesthesia, flushing and feeling hot.

In exceptional circumstances, an authorisation may be granted subject to certain specific obligations, to be reviewed annually. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicinal product, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.