Jun. 19, 2009Products
Acquisition of an additional indication of AmBisome, a therapeutic agent for systemic fungal infection
Dainippon Sumitomo Pharma Co., Ltd. (Headquarters: Osaka, Japan; President: Masayo Tada) has obtained as of June 17 a Japanese approval for an additional indication and new dosing regimen of “AmBisome® 50mg for intravenous drip infusion”, a therapeutic agent for systemic fungal infection, relating to treatment of infections caused by Mucor species and species of a few other genera as well as treatment of visceral leishmaniasis.
AmBisome®, discovered by Gilead Sciences, Inc. of the U.S., is an agent to mitigate the side-effects of amphotericin B while retaining its efficacy with regard to treatment of fungal infections by intercalating amphotericin B into a liposomal membrane formulation. This agent is sold in 46 countries outside of Japan, including the U.S., the U.K., Germany and France.
In Japan, this agent, developed by the company was launched in June 2006 with indications of “systemic mycosis, respiratory mycosis, fungal meningitis, and disseminated visceral mycosis caused by Aspergillus species, Candida species or Cryptococcus species” and “febrile neutropenia suspected to be caused by fungal infection”.
As a result of the additional indication, this agent can be more widely used than ever to cure systemic mycosis due to addition of Mucorymycosis, Histoplasmosis and a few others to the three major kinds of fungus covered by the previously approved indication. Cases of infections by imported fungus such as Histoplasmosis are feared to increase in number as international intercommunion becomes more active in the future.
Visceral leishmaniasis can be treated by AmBisome® under the newly added indication, though the same has already been allowed outside of Japan. Visceral leishmaniasis is a zoonotic infection of protozoal origin prevalent in the semitropical-to-tropical zone. There is no approved drug in Japan. This agent is thought to be an extremely important medicine as a means to cure visceral leishmaniasis particularly because of its actual medical achievements overseas.
The company expects that as a result of the additional indication and new dosing regimen AmBisome® will be able to meet the needs in medical practice more than before and contribute to furtherance of medical services.
Profile of “AmBisome® for Intravenous Drip Infusion 50mg”
|[Brand name]||AmBisome® for Intravenous Drip Infusion 50mg|
|[Generic Name]||Amphotericin B|
(The underline indicates the added part.)
|[Dosage and Administration]
|[Manufacturer and Distributor]||Dainippon Sumitomo Pharma Co., Ltd.|