Regulator approves new drug for chronic Hepatitis B patients

HI-EISAI PHARMACEUTICAL Inc., a subsidiary in the Philippines of Eisai Co., Ltd., recently announced that the Bureau of Food and Drugs (BFAD) approved Clevudine as a Nucleoside Reverse Transcriptase Inhibitor.

It is indicated for the inhibition of virus replication in chronic hepatitis B patients (HBeAg positive or HBeAg negative) with evidence of active viral replication and elevations in serum aminotransferases (ALT or AST).

Clevudine is an antiviral drug with an inhibitory effect on DNA polymerase for the treatment of chronic Hepatitis B. In the Philippines, about eight million people are believed to be infected with Hepatitis B.

With its potent and sustained anti-viral effect, Clevudine is expected to be a new treatment option for patients with deterioration in liver function caused by Hepatitis B.

Clevudine will be available in the country soon. Meanwhile, B patients are advised to seek medical consultation from health care professionals.

Dr. Jose Sollano, president of the Hepatology Society of the Philippines, said that the introduction of new compounds effective against the Hepatitis B virus strengthens our resolve to pursue relentlessly the treatment of chronic Hepatitis B.

It also gives the patients good reason to commit to the therapy immediately, in as much as the desired outcomes of treatment are now attainable.

This development complements well for the doctors’ desire at tailor-fitting certain drug treatments to individual patients in order to ensure a successful outcome of their chosen treatment against chronic hepatitis B.

Eisai obtained exclusive right to develop, manufacture and market Clevudine in eight Asian countries including China from Bukwang Pharma, a South Korean pharmaceutical company, and has been developing Clevudine in those countries.

The Philippines is the first country among them to get approval of Clevudine for marketing. Eisai is currently proceeding with the preparations for filing for approval of Clevudine in the remainder of the countries.

Eisai develops and markets drugs for liver diseases that include Stronger Neo-Minophagen C_, Glycyron_ and Livact_ in China and other Asian countries.

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