Shire has unveiled clinical trial data showing that its Gaucher disease drug Vpriv outperformed its rival, Genzyme's Cerezyme, on a score of bone mineral density (BMD).
The drugmaker said that in a head-to-head trial of the two medicines, only patients treated with its Vpriv (velaglucerase alfa) experienced a statistically significant improvement in lumbar spine BMD after nine months of treatment.
Measuring BMD can help determine the impact of Gaucher disease on a patient’s bone and can therefore help clinicians make decisions on whether treating Gaucher related bone disease is appropriate, so is an important aspect on managing the condition.
The Phase III results show that median lumbar spine Z-scores (mineral matter per square centimeter of bone) at baseline were -1.46 in patients treated with Vpriv and -0.86 in those treated with Cerezyme (imiglucerase), and mean changes from baseline at nine months were 0.33 and 0.06, respectively.
The data show that Vpriv improves Gaucher-related bone disease by inducing a sustained increase in BMD, which is generally less than that of people who don't have the disease, Shire said.
“Many type 1 Gaucher disease patients experience bone abnormalities,” said Professor Ari Zimran, Shaare Zedek Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel. “These study results show that Vpriv is effective in treating selected markers of Gaucher-related bone disease, allowing these patients to achieve an important therapeutic goal quickly,” he noted.