Shire's CINRYZE Receives FDA Fast Track Designation
LEXINGTON, Massachusetts, October 13, 2015 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG) today 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 recipients. CINRYZE is being studied as an adjunct treatment to Donor Specific Antibodies (DSA) reduction therapy in kidney transplant patients with acute AMR.
"There are currently no approved therapies for Antibody Mediated Rejection, a life-threatening and debilitating condition which can manifest in patients receiving kidney transplants," said Philip J. Vickers, Ph.D., 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 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.
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 that demonstrate the potential to address unmet medical needs. Fast Track designation may provide increased opportunities to interact and meet with FDA, and potentially increases the likelihood of being eligible for priority review if relevant criteria are met.
CINRYZE is currently only approved for, and should only be used to treat, routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
About Antibody Mediated Rejection (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) may be a contraindication to transplantation due to the risk of AMR, however DSA can also form after a transplant takes place. AMR can be life threating and debilitating to the transplant recipient, often times resulting in declining organ function and reduced graft survival.
CINRYZE is currently approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. HAE is a rare genetic disease characterized by recurrent sudden attacks of swelling of the skin or the mucous membranes which can be disfiguring, painful and potentially life-threatening in the case of laryngeal attacks.
CINRYZE® (C1 esterase inhibitor [human]) is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE).
Important Safety Information
You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.
Tell your healthcare provider about all of your medical conditions, including if you:
- have an indwelling catheter/access device in one of your veins.
- have a history of blood clots, heart disease, or stroke.
- are taking birth control pills or androgens.
- are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.
Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- difficulty breathing
- chest tightness
- turning blue (look at lips and gums)
- fast heartbeat
- swelling of the face
Serious blood clots may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:
- pain and/or swelling of an arm or leg with warmth over the affected area
- discoloration of an arm or leg
- unexplained shortness of breath
- chest pain or discomfort that worsens on deep breathing
- unexplained rapid heart rate
- numbness or weakness on one side of the body
Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common side effects seen with CINRYZE were headache, nausea, rash, and vomiting. These are not all the possible side effects of CINRYZE. Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report side effects to Shire Medical Information at 1-866-888-0660, press #2.
Please see Full Prescribing Information. http://pi.shirecontent.com/PI/PDFs/Cinryze_USA_ENG.pdf
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