Novartis drug Zortress® is first in over a decade approved by FDA to prevent organ rejection in adult liver transplant patients
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Novartis drug Zortress® is first in over a decade approved by FDA to prevent
organ rejection in adult liver transplant patients
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* Zortress is the first mTOR inhibitor approved to prevent organ rejection in
adult liver transplant patients in the US, where it is already approved for
kidney transplantation
* Approval based on positive outcomes from largest liver transplant study
ever, comparing Zortress plus reduced-exposure tacrolimus to standard
tacrolimus[1]
* Under trade name Certican(®), the drug was approved by European Health
Authorities for use in adult liver transplant patients in the fourth quarter
of 2012
Basel, February 15, 2013 - Novartis announced today that the US Food and Drug
Administration (FDA) has approved Zortress(®) (everolimus) for the prophylaxis
of organ rejection in adult patients receiving a liver transplant. Zortress is
the first mammalian target of rapamycin (mTOR) inhibitor approved for use
following liver transplantation. It is also the first immunosuppressant approved
by the FDA in over a decade for use following liver transplantation[1].
"Novartis has been a leading innovator in the transplant field for 30 years, and
this FDA approval for liver transplantation marks an important milestone for
patients and their transplant physicians in the US," said David Epstein,
Division Head of Novartis Pharmaceuticals. "This second indication for Zortress
in just three years in the US follows the recent European approval, further
underscoring Novartis' continued commitment to bringing much needed treatment
options to the transplant community worldwide."
The approval was based on the largest liver transplant study to date, which
showed that Zortress plus reduced tacrolimus led to comparable efficacy and
10mL/min higher renal function as measured by estimated glomerular filtration
rate (eGFR) for Zortress compared to standard tacrolimus at 12 months[1].
A large independent registry study of nearly 70,000 patients who received a non-
renal solid organ transplant between 1990 and 2000 showed that the incidence of
chronic renal failure was greater in liver transplant recipients than in
recipients of all other solid organ transplants, except intestinal
transplants[2]. Calcineurin inhibitors (CNIs), such as tacrolimus, are part of
the standard-of-care treatment regimen for immunosuppression in liver
transplantation, but they can contribute to adverse reactions, including
impaired renal function[3],[4]. Zortress works by binding to a protein called
mTOR, and acts synergistically with CNIs, offering an opportunity to lower CNI
exposure[1],[5].
European Health Authorities approved Certican(®) (everolimus) for the
prophylaxis of organ rejection in adult patients receiving a liver transplant in
the fourth quarter of 2012. In most EU member countries, Certican is also
approved in kidney and heart transplantation. In the US, Zortress is already
approved for use in adult kidney transplant patients[1].
Pivotal Study Details: Zortress Plus Reduced-Exposure Tacrolimus
The US approval was based on 12-month results from a Phase III, multicenter,
open-label, randomized, controlled study conducted in 719 liver transplant
patients starting 30 days post-transplant. In the study, during the first 30
days after transplant and prior to randomization, patients received tacrolimus
and corticosteroids, with or without mycophenolate mofetil. No induction
antibody was administered[1].
Thirty days following liver transplantation, patients were randomized to one of
three groups: Zortress (C(0) 3-8ng/mL) plus reduced-exposure tacrolimus (C(0)
3-5ng/mL) (n=245), Zortress (C(0) 6-10ng/mL) followed by tacrolimus withdrawal
at four months (n=231) or standard-exposure tacrolimus (C(0) 6-10ng/mL) only
(control, n=243). All three study arms included twice-daily treatment.
Additionally, all arms included corticosteroids for at least six months post-
transplant.Enrollment into the tacrolimus withdrawal arm was prematurely halted
due to a higher incidence of acute rejection episodes and adverse reactions
leading to treatment discontinuation, clustered around the time of tacrolimus
elimination at four months post randomization. Therefore, a treatment regimen of
Zortress with tacrolimus elimination is not recommended[1],[6].
The efficacy failure endpoint at 12 months included treated biopsy proven acute
rejection (tBPAR), graft loss, death or loss to follow-up by month 12. Loss to
follow-up represented patients who did not experience tBPAR, death or graft
loss, and whose last contact date was prior to the 12-month visit. Study results
showed that Zortress plus reduced-exposure tacrolimus was comparable to
standard-exposure tacrolimus with respect to efficacy failure. The incidence of
efficacy failure was lower in the Zortress plus reduced-exposure tacrolimus
group compared to the tacrolimus control group at month 12 (9% vs. 13.6%,
respectively). The difference in rates (Zortress vs. control) with 97.5% CI for
the efficacy failure endpoint was -4.6% (-11.4%, 2.2%) and the difference in
rates for the graft loss, death or loss to follow-up endpoint was -0.1% (-
5.4%, 5.3%)[1].
The main safety objective was evolution of renal function. The estimated mean
glomerular filtration rate for the Zortress plus reduced-exposure tacrolimus
group was 80.9 mL/min/1.73m(2) and the tacrolimus control group was 70.3
mL/min/1.73m(2) at 12 months post-transplant in the intent-to-treat (ITT)
population[1].
Please see US prescribing information at:
http://www.pharma.us.novartis.com/product/pi/pdf/zortress.pdf.
About Zortress (everolimus)
Everolimus is one of the most-extensively studied immunosuppressants in solid
organ transplantation with more than 10,000 transplant recipients enrolled in
Novartis-sponsored clinical trials worldwide[7]. Under the trade name
Certican(®), it is approved in more than 90 countries to prevent organ rejection
for renal and heart transplant patients, and in addition, is approved in the EU
and other countries worldwide to prevent organ rejection for liver transplant
patients. In the US, under the trade name Zortress(®), the drug is approved for
the prophylaxis of organ rejection in adult patients at low-moderate immunologic
risk receiving a kidney transplant, and is also approved in adult patients
following a liver transplant.
Everolimus is also available from Novartis in different dosage strengths and for
different uses in non-transplant patient populations under the brand names
Afinitor(®) and Votubia(®). It is also exclusively licensed to Abbott and
sublicensed to Boston Scientific for use in drug-eluting stents.
Not all indications are available in every country. As an investigational
compound, the safety and efficacy profile of everolimus has not yet been
established outside the approved indications. Because of the uncertainty of
clinical trials, there is no guarantee that everolimus will become commercially
available for additional indications anywhere else in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "will," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for everolimus, or regarding potential future revenues from everolimus. You
should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause
actual results with everolimus to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that everolimus will be submitted or approved for any
additional indications or labeling in any market, or at any particular time. Nor
can there be any guarantee that everolimus will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
everolimus could be affected by, among other things, unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions or delays or
government regulation generally; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures; unexpected
manufacturing issues; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as recorded in
the Group's consolidated balance sheet, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 128,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Zortress(®) (everolimus) US Prescribing Information, February 2013.
[2] Ojo, A., Held, P., Port, F., et al. Chronic Renal Failure after
Transplantation of a Nonrenal Organ. New Eng J Med, 2003;349:931-940.
[3] McGuire B.M., Rosenthal P., Brown C.C., et al. Long-term Management of the
Liver Transplant Patient: Recommendations for the Primary Care Doctor. Am J
Transplant, 2009;9:1988-2003.
[4] Venkataramanan, R., Shaw, L.M., Sarkozi, L., et al. Clinical Utility of
Monitoring Tacrolimus Blood Concentrations in Liver Transplant Patients. J Clin
Pharmacol, 2001;41:542-551.
[5] Schuurman, HJ., Cottens, S., Fuchs, S., et al. SDZ RAD, A New Rapamycin
Derivative: Synergism with Cyclosporine. Trans, 1997;64,1;32-35.
[6] De Simone, P., Nevens, F., De Carlis, L., et al. Everolimus with reduced
tacrolimus improves renal function in de novo liver transplant recipients: a
randomized controlled trial. Am J Transplant. 2012.
[7] Novartis Data on File. July 2012.
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Datum: 15.02.2013 - 22:31 Uhr
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