BRIDGEWATER, N.J., April 24, 2017 /PRNewswire/ -- Sanofi
today announced that the U.S. Food and Drug Administration (FDA)
approved Thymoglobulin® [anti-thymocyte globulin
(rabbit)], for use in conjunction with concomitant
immunosuppression in the prophylaxis, or prevention, of acute
rejection in patients receiving a kidney transplant.
Kidney disease is the ninth leading cause of death in the US;
468,000 patients are currently on dialysis for kidney failure,
including an estimated 100,000 who are waiting for a kidney
transplant. Kidney transplantation offers patients with
end-stage renal disease longer survival and better quality of life
compared to dialysis. With kidney transplantation, however, there
is a risk of acute rejection, which can lead to graft complications
and potential loss of the transplanted kidney.
"Thymoglobulin has been a well-established medication used in
kidney transplantation for nearly 20 years, and this FDA approval
is an important milestone for the transplant community," said
Daniel Brennan, MD, Professor of
Medicine, Director of Transplant Nephrology, Barnes-Jewish Hospital
of Washington University School of
Medicine in St. Louis.
"Transplant rejection can be particularly discouraging for
patients. The use of Thymoglobulin beginning just prior to
transplantation may be an important step to ensuring a successful
kidney implantation."
"Sanofi has been connected and committed to the kidney
transplant community for decades. This FDA approval of
Thymoglobulin for prophylactic use underscores our continued
commitment to patients and their caregivers who will be receiving a
potentially life-saving kidney transplant," said David Meeker, MD, Executive Vice President and
Head, Sanofi Genzyme. "We remain focused on developing
treatments for patients in need of new medications for
life-threatening and limiting illnesses, including patients
receiving a kidney transplant."
The FDA approval was based on two randomized multicenter studies
comparing Thymoglobulin to interleukin-2 receptor antagonists
(IL2RA: basiliximab or daclizumab) in deceased donor kidney
transplant recipients. The first study in kidney transplant
patients (n=278) at increased risk of acute rejection or delayed
graft function showed a significantly lower incidence of the
treatment failure as measured by a composite endpoint
(biopsy-proven acute rejection, graft loss, death or lost to
follow-up) within 12 months following transplantation in the
Thymoglobulin group compared to patients in the basiliximab group
(25 percent versus 38 percent; p=0.02).
The second study was an investigator-sponsored study in kidney
transplant patients (n=230) at high immunological risk of
rejection. Patients received either Thymoglobulin or daclizumab and
also showed a lower incidence of treatment failure as measured by
the composite endpoint 12 months following transplantation (25
percent versus 34 percent). The estimated between-treatment
group difference (Thymoglobulin to daclizumab) was -9% (95% CI,
-19.9% to 3.6%) demonstrating non-inferiority of Thymoglobulin
compared with daclizumab.
The pooled analysis of both studies (n=508) showed a composite
endpoint rate within 12 months post transplantation of 25.1 percent
in the Thymoglobulin group compared with 36.0 percent in the IL2RA
group. The estimated between-treatment group difference
(Thymoglobulin to IL2RA) was -10.9% (95% CI, -18.8% to - 2.9%),
which demonstrates superiority of Thymoglobulin for the prevention
of acute rejection.
The most frequent adverse reactions seen in these clinical
trials (more than 25% of patients receiving Thymoglobulin) include:
leukopenia, hyperkalemia, urinary tract infection and pyrexia.
Thymoglobulin was originally approved by US regulatory
authorities in 1998 for the treatment of renal transplant acute
rejection. Thymoglobulin is marketed by Sanofi Genzyme,
the specialty care global business unit of Sanofi.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only
be used by physicians experienced in immunosuppressive therapy in
transplantation.
- Contraindications. Thymoglobulin is contraindicated in
patients with a history of allergy or anaphylaxis to rabbit
proteins or to any product excipients, or who have active acute or
chronic infections which contraindicate any additional
immunosuppression.
- Management of Immunosupression. To prevent
over-immunosuppression, physicians may wish to decrease the dose of
the maintenance immunosuppression regimen during the period of
Thymoglobulin use. Dosing for Thymoglobulin is different from
dosing for other ATG products, because protein composition and
concentrations vary depending on the source of ATG.
White blood cell (WBC) and platelet counts should be monitored.
Monitoring the lymphocyte count may help assess the degree of
T-cell depletion.
- Immune Mediated Reactions. Serious immune-mediated
reactions, including anaphylaxis or severe cytokine release
syndrome (CRS), have been reported with the use of Thymoglobulin.
Fatal anaphylaxis has been reported. If an anaphylactic reaction
occurs, the infusion should be terminated immediately.
- Infusion-Associated Reactions. Cases consistent with
cytokine release syndrome (CRS) have been reported with rapid
infusion rates. CRS is attributed to the release of cytokines
by activated monocytes and lymphocytes. Severe acute CRS can cause
serious cardiorespiratory events and/or death. Close
compliance with the recommended dosage and infusion time may reduce
the incidence and severity of infusion-associated reactions
(IARs). Slowing the infusion rate may minimize many of these
IARs. Reactions at the infusion site may include pain, swelling,
and redness of the skin.
- Hematologic Effects. Low counts of platelets and white
blood cells (including low counts of lymphocytes and neutrophils)
have been identified and are reversible following dose
adjustments. Total white blood cell and platelet counts
should be monitored
- Infection and Malignancy. Infections, reactivation of
infection, febrile neutropenia, sepsis, malignancies including
lymphoproliferative disorders (LPD) and other lymphomas as
well as solid tumors have been reported after Thymoglobulin
administration in combination with multiple immunosuppressive
agents. These infections can be fatal.
- Immunization. The safety of immunization with attenuated
live vaccines following Thymoglobulin therapy has not been studied;
therefore, immunization with attenuated live vaccines is not
recommended for patients who have recently received
Thymoglobulin.
- Thymoglobulin should be used under strict medical supervision
in a hospital setting, and patients should be carefully monitored
during the infusion.
- Overdosage. Thymoglobulin overdosage may result in
leukopenia (including lymphopenia and neutropenia) and/ or
thrombocytopenia, which can be managed with dose reduction.
- During post-marketing surveillance, arthralgia/myalgia,
lymphadenopathy, proteinuria, and decreased oxygen saturation tend
to occur 5 to 15 days after Thymoglobulin infusion and are
consistent with serum sickness. Symptoms are manageable with
corticosteroid treatment.
- Adverse Reactions. The most common adverse reactions and
laboratory abnormalities (incidence >5% higher than comparator)
are urinary tract infection, abdominal pain, hypertension, nausea,
shortness of breath, fever, headache, anxiety, chills, increased
potassium levels in the blood, and low counts of platelets and
white blood cells.
Please CLICK HERE for full Prescribing Information including
Boxed WARNING.
INDICATION
Thymoglobulin® (anti-thymocyte globulin (rabbit)) is
indicated for the prophylaxis and treatment of acute rejection in
patients receiving a kidney transplant. Thymoglobulin is to
be used in conjunction with concomitant immunosuppression.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi is organized into five global business units: Diabetes and
Cardiovascular, General Medicines and Emerging Markets, Sanofi
Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed
in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
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Relations
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Koss
Tel:
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ashleigh.koss@sanofi.com
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Communications
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Brown
Tel:
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Mobile:
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carrie.brown@sanofi.com
|
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Relations
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SAUS.THM.17.04.1171
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