Merck Serono reports positive data for PKU drug Kuvan

Merck Serono has announced encouraging new data from a phase IIIb trial of its phenylketonuria (PKU) therapy Kuvan among infant patients.

Detailed 26-week data from the SPARK trial have shown that the addition of Kuvan to a phenylalanine-restricted diet significantly increased phenylalanine tolerance compared to the dietary intervention alone.

As such, the drug was able to meet its primary efficacy endpoint in the trial, while its safety profile conformed to the expected parameters described in its European Summary of Product Characteristics.

The positive outcome of this trial will enable the submission of an application for a label extension this year, with the study results to be submitted for publication in a peer-reviewed journal.

Luciano Rossetti, head of global research and development at Merck Serono, said: "We know that PKU can have profound and far-reaching consequences if not managed appropriately right from birth. These results add to the growing insights for the medical community around PKU in infants and young children."

This comes after the firm achieved organic growth during the second quarter of 2014, thanks in large part to rising sales of its cancer drug Erbitux.