Epogin Injection : Submission of an opinion letter on the application for approval of an additional indication for "Epogin Injection" [generic name: epoetin beta (genetic recombination)]
2011-07-26
On July 26th 2011, we submitted an opinion letter on the application for approval of an additional indication for the "Epogin Injection".
Regarding the recombinant human erythropoietin "Epogin Injection" (hereafter referred to as "the agent"), Chugai Pharmaceutical Co., Ltd filed an application on November 19th 2009 for the approval of an additional indication of "chemotherapy-induced anemia in solid tumour patients who are not eligible for curative surgery." The agent has already been approved as a treatment for renal anemia experienced by patients undergoing dialysis.
In response to this, on May 30th 2011 the Pharmaceutical and Medical Devices Agency (PMDA) concluded that EPOGIN should not be approved because the policies in place for appropriate safety management (which would avoid the risk of a worsened prognosis and promotion of cancer cell growth) are unclear, and at this stage there is no way of telling whether the benefits outweigh the risks.
On June 23rd 2011, the Evaluation and Licensing Division of the Ministry of Health, Labor and Welfare's Pharmaceutical and Food Safety Bureau started to gather public opinions on this matter. We also submitted an opinions letter.
Like the PMDA, we believe that the additional indication should not be approved, as the effects on and safety towards chemotherapy-induced anemia in solid tumour patients who are not eligible for curative surgery are yet to be established.
The agent is a supporting treatment for patients undergoing chemotherapy. Chemotherapy aims to prolong patients' lives and inhibit cancer cell growth. Under no circumstances must this fail following use of the agent.
However, there is also evidence that patients face an extremely high risk of developing blood clots or cancer tumours, both of which can shorten life expectancy. Furthermore, there is currently no method in place that mitigates these risks appropriately.
Concerning its effects, the applicant has explained that the agent increases the quality of life (QOL) of those taking it, but there is no data from clinical studies with this as a primary endpoint. In addition, there are doubts towards the benchmark used by the applicant to judge the agent's effects (blood transfusion rate) and how this and other criteria were decided upon.
Therefore, in view of the fact that patients undergoing chemotherapy can receive other forms of treatment (red blood cell transfusion), we believe the agent cannot be approved at this stage, in line with the PMDA's results.
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