3.2. Authorised medicinal products for Haemophilia
In order to understand which products had received a central market authorisation for Haemophilia A and B we carried out an investigation in EMA’s EPARs (European public assessment reports) database, which contains all scientific assessment reports of medicines authorised at a European Union level. We downloaded the table of all EPARs for human and veterinary medicines from EMA’s website. A total of 1694 medicinal products resulted from the research. We selected only medicinal products for the treatment of haemophilia A and B in human. 24 medicinal products resulted from the research. Among them, two medicinal products (Iblias and Nonafact) were withdrawn from use in the European Union (both at the request of the marketing-authorisation holder). Currently, there are 22 authorised medicinal products for the treatment of haemophilia A and B. Table 3 provides a detailed list of the authorised medicines. Among them, only Alprolix and Idelvion were designated orphan medicinal products and received a 10-years market exclusivity. The remaining authorised medicines are no longer orphan medicines and were withdrawn from the Community register of orphan medicinal products at the time of the granting of a marketing authorisation. These products did not provide any advantage compared to the current state of art, and did not brought the innovation that was hoped to transform the treatment of patients with Haemophilia A and B.