Date: 2015-10-13
Type of information: Granting of a Fast Track status
Product name: Cinryze®
Compound: C1 esterase inhibitor
Therapeutic area: Transplantation - Renal diseases - Kidney diseases
Action mechanism:
- enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema. Cinryze® is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
- Cinryze® was developed by Viropharma that has been acquired by Shire in 2014.
Company: Shire (UK - USA)
Disease:
- subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients
Latest news:
- • On October 13, 2015, Shire announced that the FDA has granted Fast Track designation for the investigation of Cinryze® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients. Cinryze® is being studied as an adjunct treatment to Donor Specific Antibodies (DSA) reduction therapy in kidney transplant patients with acute AMR. Shire is planning a Phase 3 multi-center, multi-national, randomized, double-blind, placebo-controlled study (SHP616-302) to evaluate the efficacy of Cinryze® (intravenous administration) as an adjunct to DSA reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) for the treatment of acute AMR in kidney transplant recipients. The trial will be conducted in the United States, Europe and Canada and the study will open for enrollment by the end of October 2015.
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:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
