The Drug Controller General of India is likely to call off the ongoing clinical trials of Novartis' drug Certican in the wake of a recent negative safety report of the US Food and Drug Administration.
Certican (everolimus) is one of the latest drugs from Novartis' portfolio to treat prophylaxis of organ rejection in adult patients receiving a heart or renal transplant.
In a recent review of the Novartis' new drug application, a majority of the cardiovascular and renal advisory committee of the US FDA had narrowly rejected support for an approval, citing concerns related to negative safety profile generated by the clinical trials.
Though the committee agreed that the clinical trial data supported efficacy, it did not prove safety and indicated high levels of renal toxicity as a primary concern.
In India, Certican was approved for trials in renal transplant patients. Currently, Novartis is conducting clinical trials of this drug on a number of patients at multiple centres across the country.
A source from DCGI's office told Business Standard that the department was going to ask the company to immediately stop the trials as the safety profile of the drug was reportedly not satisfactory.
"Normally, when there are reports of toxicity risks like this, the companies are urgently required to bring it to the notice of the regulator. However, following the US FDA's negative report on the drug safety, we will look into the matter more seriously and there will be an immediate action," the source said.
A Novartis India spokesperson said the cardio renal advisory committee of the US FDA recommended the provision of additional data from controlled trials with Certican and reduced dose of Neoral regimen in heart transplant patients to finalise US approval.
"This can be interpreted as an endorsement of Certican and the additional data will provide more specific dosing information that reflects the current standards of practice in immunosuppressant use in the US hospitals. Standards of practice in immunosuppressant use do differ across global regions and these may impact on dosing guidelines," the Novartis source said.
Currently, there are three global trials with Certican involving over 1,000 heart transplant recipients worldwide.
The Novartis India spokesperson added that Certican has been approved as safe and effective for prevention of rejection in kidney and heart transplantation recipients in over 48 countries worldwide.
As a commitment to the transplant community, Novartis is conducting trials in kidney and heart transplantation to further refine the use of Certican in clinical practice.
Bitter pill
