Date: 2017-02-13
Type of information: Granting of a Market Authorisation in the EU
Product name: Vihuma®
Compound: simoctocog alfa (recombinant blood coagulation factor VIII)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Action mechanism: protein/coagulation factor. Simoctocog alfa is a recombinant blood coagulation factor VIII (B02BD02) - a replacement therapy to increase plasma levels of factor VIII, thereby temporarily enabling a correction of the factor VIII deficiency and correction of the bleeding tendencies.
Company: Octapharma (Switzerland)
Disease: hemophilia A
Latest news: • On February 13, 2017, the European Commission has approved Vihuma® for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency). • On December 15, 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Vihuma®, intended for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency). Vihuma® will be available as a powder (250 IU, 500 IU, 1000 IU and 2000 IU) and solvent for solution for injection. Vihuma has been shown to be effective at preventing and treating bleeding in 3 pivotal trials. No side effects were commonly reported in the safety database of 135 previously treated patients. The immunogenicity of the medicine was evaluated in clinical trials in 135 previously treated patients with severe haemophilia A (74 adult and 61 paediatric patients). None of the patients developed inhibitors. Vihuma® has been submitted as an informed consent application. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for Vihuma® is Nuwiq®.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-02-13
Favourable opinion UE: 2016-12-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
