Shire’s Cinryze gets FDA fast track designation
pharmafile | October 13, 2015 | News story | Research and Development | AMR, FDA, Shire
Shire has announced that the United States Food and Drug Administration (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 procedures.
Cinryze is being studied as an adjunct treatment to Donor Specific Antibodies (DSA) reduction therapy in kidney transplant patients with acute AMR.
AMR is a condition that sometimes occurs in patients following solid organ transplantation and is initiated by the presence of DSA in the transplant recipient. DSA identified prior to transplant (pre-formed) and the risk of AMR it causes can rule out transplantation, however DSA can also form after a transplant procedure.
AMR can be life threating and debilitating to the transplant recipient, often times resulting in declining organ function and reduced graft survival.
“There are currently no approved therapies for Antibody Mediated Rejection, a life-threatening and debilitating condition which can manifest in patients receiving kidney transplants,” says Philip Vickers, head of Research and Development at Shire.
“The Fast Track designation represents an understanding of the significant unmet medical need for this condition. Shire looks forward to working closely with the FDA as we continue to study Cinryze as a potential treatment option for these patients.”
Shire is planning a Phase III trial (SHP616-302) of Cinryze as an adjunct to DSA reduction therapy 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.
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Cinryze is currently only approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE): a rare genetic disease that causes sudden swelling of the skin or the mucous membranes which can be disfiguring, painful and potentially life-threatening in the case of laryngeal attacks.
Shire acquired the rights to Cinryze with its $4.2 billion purchase of ViroPharma in 2013.
Joel Levy
Related Content
EndoCyclic New Drug application approved by US FDA for endometriosis treatment
EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
