FUJIFILM Corporation (President: Shigehiro Nakajima) announced that the French National Institute of Health and Medical Research (Inserm)**
released today an interim analysis of the clinical trial suggesting the efficacy of anti-influenza drug Avigan® Tablet 200mg*
(Favipiravir), which is being provided to clinical trials in Guinea for patients with Ebola Virus Disease (EVD).
- For patients group with a high or moderate viral load at the beginning of treatment ***, the rate of mortality when compared to treatment results of patients of the same level who received basic care *4 in the three months preceding the trial was halved (30% → 15%), demonstrating encouraging signs of efficacy.
- For patients group with a very high viral load at the beginning of treatment *5, 81% had refractory renal failure when arriving at the treatment center, and a signal that the administration of Avigan® Tablets led to a decreased mortality rate was unable to be demonstrated.
- Although compared to influenza treatment high doses were administered for ten days, adverse events were not observed.
Details about the results of the interim analysis are scheduled to be announced at the Conference on Retroviruses and Opportunistic Infections (CROI) to be held in Seattle on February 25.
The anti-influenza drug Avigan® Tablets was developed by the Fujifilm Group company Toyama Chemical Co., Ltd. Results of mouse experiments showing the antiviral effect of Avigan® Tablets against EVD have been published, and Avigan® Tablets have already been administered as an emergency response to multiple patients infected with EVD. Following this, from December 17 last year, Inserm conducted clinical trials at four EVD treatment centers in Guinea to investigate the efficacy of Avigan® Tablets for the treatment of EVD patients.*6
Interim analysis results from the first 80 cases of this clinical trial have been published.
“Given that the efficacy of Avigan® Tablets for the treatment of EVD is suggested, the Fujifilm Group will continue to contribute to the termination of the EVD infection, and fully cooperate with the governments of France and Guinea, as well as the relevant authorities in Japan towards establishing a treatment for EVD”
said Takatoshi Ishikawa, Senior Vice President, General Manager of Pharmaceutical Products Division at FUJIFILM Corporation.
The Japanese government has announced that it is prepared to provide drugs developed by Japanese companies that might prove effective in the treatment of EVD. Fujifilm will continue to respond to the requests of the various countries with infected patients while discussing with the Japanese government.
- * Developed by Toyama Chemical and approved in Japan as anti-influenza drug in March 2014.
- ** Abbreviateion for the Institut national de la santé et de la recherche médicale.
- *** The number of copies of the virus in 1mL of blood is 108 or less
- *4 Treatment method for rehydration and to replenish nutrition
- *5 The number of copies of the virus in 1mL of blood is 108 or greater
- *6 This clinical trial has been given the name “JIKI,” meaning hope in the local language. Inserm is receiving funding from the EU to conduct clinical trials at four EVD treatment facilities in Guinea, Guékédou, Nzérékoré, Macenta, and Conakry, in cooperation with NGO's providing medical care to EVD patients (MSF [Doctors Without Borders], ALIMA [Alliance for International Medical Action], and the French Red Cross).
For inquiries on information in this media release, contact:
</dt><dd>Corporate Communications Division
</dt><dd>Pharmaceutical Products Division