AASLD - Novartis' Certican succeeds in liver transplant trial
(Reuters) – Swiss pharmaceutical company Novartis said on Monday its Certican, an immune system drug also known under the names Afinitor and Votubia, showed positive outcomes in a two-year phase III study in liver transplantation.
The study, which Novartis said was the largest liver transplant trial to date, confirmed the comparative effectiveness of the treatment and the improved renal function in patients previously noted at the 12-month stage.
The trial evaluated the introduction of Certican (everolimus) with reduced exposure of another immunosuppressive drug tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus, Novartis said.
The data were presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
Certican was approved by European health authorities for use in adult liver transplant patients in October 2012. A decision by the US Food and Drug Administration is expected by the end of 2012, Novartis said.
Under the trade name Certican, everolimus is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients, Novartis said.
(Reporting by Silke Koltrowitz; Editing by Hans-Juergen Peters)
Novartis new two-year data with Certican® shows positive outcomes at 24 months in largest liver transplant trial to date
Study’s endpoints met; Certican with reduced exposure tacrolimus provided comparable efficacy with superior renal function maintained from month one to 24 versus control arm [1]
Calcineurin inhibitors like tacrolimus are part of the standard immunosuppression regimen after a liver transplant but may contribute to a decline in renal function over time [2],[3]
Certican was approved by European Health Authorities for use in adult liver transplant patients in October 2012
Basel, November 12, 2012 -
The 24-month results are from a Phase III, multicenter, open-label, randomized, controlled study conducted in 719 de novo liver transplant patients.Four weeks following liver transplantation, patients treated with tacrolimus and corticosteroids (with or without mycophenolate mofetil) were randomized to one of three groups: Certican (C0 3-8ng/mL) in combination with reduced-exposure tacrolimus (C0 3-5ng/mL) (n=245), Certican (C0 6-10ng/mL) followed by tacrolimus withdrawal at four months (n=231) or standard-exposure tacrolimus (C0 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 events leading to treatment discontinuation, clustered around the time of tacrolimus elimination at four months post randomization[1]. The study protocol was amended at that time.
Everolimus is the most-extensively studied immunosuppressant in solid organ transplantation with more than 10,000 transplant recipients enrolled in Novartis-sponsored clinical trials worldwide[9].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, Chile and Philippines 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.
The foregoing release contains forward-looking statements that can be identified by terminology such as “may,” “commitment,” “potential,” “promising,” “suggest,” “can,” “expected,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for everolimus, potential additional marketing approvals 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 sale, or 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 regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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.
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 2011, the Group’s continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
- Saliba, F., De Simone, P., Nevens, F., et al. Everolimus-Facilitated Reduction of Tacrolimus Provides Comparable Efficacy and Superior Renal Function Versus Standard Tacrolimus In de novo Liver Transplant Recipients: 24-Month Results of a Randomized Trial. To be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases; November 9-13, 2012; Boston, MA, USA.
- McGuire B.M., Rosenthal P., Brown C.C., et al. Long-term Management of the Liver Transplant Patient: Recommendations for the Primary Care Doctor. American Journal of Transplantation 2009; 9: 1988-2003.
- 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.
- 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.
- Certican® Prescribing Information.
- Schuurman, HJ., Cottens, S., Fuchs, S., et al. SDZ RAD, A new rapamycin derivative: Synergism with cyclosporine. Trans, 1997;64,1;32-35.
- 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. American Journal of Transplantation. 2012.
- Saliba, F., De Simone, P., Nevens, F., et al. Everolimus-Facilitated Reduction of Tacrolimus Provides Comparable Efficacy and Superior Renal Function Versus Standard Tacrolimus In de novo Liver Transplant Recipients: 24-Month Results of a Randomized Trial. Abstract.
- Novartis Data on File: DSUR. July 2012.
http://www.novartis.com/newsroom/index.shtml
2012-11-12 20:26:59
Source: http://hepatitiscnewdrugs.blogspot.com/2012/11/aasld-novartis-certican-succeeds-in.html
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