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Sparks commentary - IRLAB Therapeutics

Healthcare

Sparks - IRLAB Therapeutics

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IRLAB (OMX: IRLAB-A) receives EMA waiver for mesdopetam paediatric studies
Published by Arron Aatkar, PhD

IRLAB has announced that it has received a waiver from the European Medicines Agency, which means it does not have to perform studies of its lead asset, mesdopetam, in children. This would otherwise have been mandatory to support a European marketing authorisation application. Consequently, IRLAB can now focus its efforts in patient groups where Parkinson’s disease (PD) is more prevalent, such as in older populations, and hence avoid resource-demanding and lengthy studies in the paediatric population.

Mesdopetam is IRLAB’s lead clinical candidate, which is being developed as a potential treatment for levodopa-induced dyskinesias in PD patients. The company is currently preparing for Phase III.

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