Novartis receives US FDA approval for Zortress® (everolimus) to prevent organ rejection in adult kidney transplant recipients
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Novartis International AG / Novartis receives US FDA approval for Zortress® (everolimus) to prevent organ rejection in adult kidney transplant recipients processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Zortress offers kidney transplant recipients a new option for preventing
organ rejection and preserving kidney function with reduced doses of
cyclosporine[1]
* Preventing organ rejection while reducing the side effects of treatment
regimens containing cyclosporine is a major challenge in kidney
transplantation[2]
* Zortress inhibits the proliferation of cells that play a key role in
transplant rejection[3]
* First approved outside the US over six years ago as Certican®, everolimus is
an established transplant immunosuppressant therapy in more than 70
countries
Basel, April 22, 2010 - The US Food and Drug Administration (FDA) has approved
Zortress (everolimus) oral tablets for the prevention of organ rejection of
kidney transplants in adult patients at low-to-moderate immunologic risk.
Zortress is to be given in combination with reduced doses of the calcineurin
inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids[4].
Under the brand name Certican(®), everolimus is already an established part of
the immunosuppressive regimen for transplant patients in more than 70 countries
outside the US.( )
"For patients who require a kidney transplant, the limited availability of
organs underscores the urgent need for effective medicines that can help protect
the survival of the transplanted organ for the patient," said David Epstein,
Division Head of Novartis Pharmaceuticals. "Our commitment to transplant
patients exceeds 25 years, and Zortress is the latest addition to our growing
portfolio. This includes five medications that enable clinicians to provide
various treatment options to help manage their individual kidney transplant
patients."
FDA approval of Zortress was based on results from the largest single Phase III
registration study ever conducted in kidney transplant recipients. In the study,
Zortress prevented acute organ rejection and preserved kidney function while
allowing, on average, 60% lower doses of the CNI cyclosporine to be used
compared with the control regimen of mycophenolic acid (MPA) with full dose
cyclosporine and corticosteroids. Use of Zortress led to a reduction in
CNI-associated side effects while maintaining good efficacy[1].
Calcineurin inhibitors, which are part of the typical immunosuppressive regimen,
have been associated with injury to the kidneys and, when used in a
combination-immunosuppressant regimen, increase the risk of infections and
malignant tumors[3].
Following transplantation, immunosuppressive medicines are required to protect
the transplanted organ from being rejected by the recipient's immune system.
Antigen-activated T cells play a key role in transplant rejection by recognizing
foreign substances and multiplying in an attempt to protect the body. Zortress
acts as an immunosuppressant by binding to a protein called mammalian target of
rapamycin (mTOR) and preventing the proliferation of these antigen-activated T
cells[3].
"Transplant recipients require lifelong immunosuppression, so there is a
critical need for treatment regimens that protect the transplanted kidney, and
also reduce the side effects and infections associated with calcineurin
inhibitors," said Diane M. Cibrik, MD, Associate Professor of Medicine and
Medical Director of Transplant Clinical Research Trials at the University of
Michigan. "Based on its different mode of action, Zortress offers the ability to
reduce calcineurin inhibitors, and may help to address this unmet need."
In 2009, an estimated 16,800 kidney transplants were performed in the US, and an
estimated 4,500 kidney transplant candidates died while awaiting organ donation.
As of March 2010, there were more than 83,000 patients awaiting kidney
transplantation in the US[5].
Organ survival rates one year after a successful kidney transplant range from
89% when the organ comes from a deceased donor to 95% when the donor is living.
However, percentages drop five years after transplantation with survival rates
of approximately 67% and 80% respectively[5].
Zortress has been approved in the US with a Risk Evaluation and Mitigation
Strategy (REMS) to help guide patients and healthcare providers on the safe use
and risks of Zortress following kidney transplantation. The approved REMS
includes a medication guide, a communications plan and a timetable for
submission of assessments.
The most common (? 20%) adverse events observed with Zortress are peripheral
edema, constipation, hypertension, nausea, anemia, urinary tract infection and
hyperlipidemia. Events such as peripheral edema, dyslipidemia and hyperlipidemia
were at least 5% higher in patients given Zortress with reduced-dose
cyclosporine than in those given mycophenolic acid and full-dose
cyclosporine[4].
Increased susceptibility to infection and possible development of malignancies
may result from immunosuppression. Potential serious adverse events associated
with Zortress include lymphoma and other malignancies, as well as serious
infections. Increased risk of kidney graft thrombosis has also been reported
with Zortress. Therapeutic drug monitoring of everolimus and cyclosporine is
recommended for all patients receiving these products.
The active ingredient in Zortress is everolimus, which was first approved in
2003 under the brand name Certican and is used for kidney and heart
transplantation in more than 70 countries outside the US. A Phase III study
using everolimus in heart transplant is under way to support US filing, and a
worldwide Phase III liver transplant study is ongoing.
Everolimus is also available in different dosage strengths under the brand name
Afinitor(®) for the treatment of advanced renal cell carcinoma (RCC) after
failure of treatment with sunitinib or sorafenib. Afinitor was approved in the
US in 2009.
About Novartis Transplant Medicines
As a company committed to research, development and the marketing of therapies
that improve health, ease suffering and enhance patients' quality of life,
Novartis is a leader in transplantation and immunology. With the discovery and
introduction of cyclosporine more than 25 years ago, Novartis has contributed to
improving treatment options for transplant patients and now has the broadest
portfolio of immunosuppressants on the market.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "risk," "may," "potential," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for medicines containing the active ingredient
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 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 approved for any additional indications or labeling in
any market. 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; 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com
References
[1] Tedesco Silva H., et al. Everolimus with reduced-dose cyclosporine as a
strategy for optimizing long-term renal function: Results from a
randomized study in 833 de novo renal transplant recipients. ESOT poster
presentation; ESOT 2009.
[2] Cibrik D. et al. Everolimus plus reduced-exposure CsA vs mycophenolic
acid plus standard exposure CsA in renal-transplant recipients. Novartis
internal document; 2009.
[3] Mange K., Lee L. Briefing Book for Cardiovascular and Renal Drugs
Advisory Committee Meeting. Novartis Internal Document; 2009.
[4] Zortress(®) Prescribing Information. April 2010.
[5] OPTN Organ Procurement and Transplant Network Database.
http://optn.transplant.hrsa.gov/latestData/rptData.asp. Accessed: April
20, 2010.
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Novartis International AG
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Datum: 22.04.2010 - 07:15 Uhr
Sprache: Deutsch
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