NEW HEP B DRUG APPROVED IN JAPAN

19 June 1994

The Japanese regulatory authorities have approved Sanwa Kagaku Kenkyusho's Serocion Cap (propagermanium) for the treatment of chronic hepatitis B infection. This orally-active agent is an organic germanium compound and, while it has no direct antiviral activity, it seems to act by stimulating killer T cells and macrophages to produce interleukins and interferons, thereby inhibiting the growth and spread of the virus.

In clinical trials, propagermanium was found to have a clinical efficacy of an order similar to interferon preparations which are already on the market for this indication. However, the company claims the drug is easier to administer, allowing outpatient treatment, and has fewer side effects. Fever symptoms are a common problem with interferons and often limit treatment. The main adverse reactions were skin rash, itchiness, anorexia and gastrointestinal symptoms. The company has also filed for approval to market Serocion for hepatitis C infection.

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