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and Nonafact) were withdrawn from use in the European Union (both at the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authorised medicines are no longer orphan medicines and were withdrawn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.