Posted by Michael Wonder on 28 Nov 2018
Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A
26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control of bleeding episodes.
Shire Canada is pleased to announce that on 21 November 2018 Health Canada authorised the extended indication for Adynovate [anti-haemophilic Factor (Recombinant), PEGylated] for children under the age of 12 living with haemophilia A.
The safety and efficacy of Adynovate was evaluated in a total of 73 paediatric previously treated patients with severe haemophilia A, of which 66 subjects were dosed (32 subjects aged <6 years and 34 subjects aged 6 to <12 years).
