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Home Industry News Baxalta reports positive data from paediatric study of Adynovate

Baxalta reports positive data from paediatric study of Adynovate

30th December 2015

Baxalta has announced new clinical data showing the effectiveness of its haemophilia A therapy Adynovate in the treatment of paediatric patients.

Topline results from the phase III trial find no inhibitors to Adynovate treatment were reported among patients aged under 12 years, while nearly 73 percent of treated subjects experienced zero joint bleeds.

Moreover, nearly 40 percent of the 73 patients involved experienced zero bleeds of any kind, with the median annualised bleeding rate shown to be comparable to the rates seen in the previous adult study.

It means the drug – which was approved in the US for use among adolescent and adult haemophilia patients in November – was able to meet its key endpoint goals in the study.

Dr John Orloff, head of research and development and chief scientific officer at Baxalta, said: "We will continue to build evidence on the value of Adynovate through our robust clinical development programme, which will support additional global registrations in the coming years."

Baxalta expects to file for paediatric approval of Adynovate in the US in early 2016.ADNFCR-8000103-ID-801809064-ADNFCR

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