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Regulators to add condition for approving chronic hepatitis B therapy
  • By Lee Hye-seon
  • Published 2017.08.07 17:42
  • Updated 2017.08.07 17:42
  • comments 0

The Ministry of Food and Drug Safety will add the result of analyzing childhood tolerance to the approval conditions of 140 products which contain Entecavir, a compound of chronic B hepatitis therapy.

The decision was part of the unified adjustment plan of Entecavir-containing treatments the ministry announced last Wednesday. It was aimed to add cumulative incidence of childhood tolerance, as the result of analyzing clinical trials conducted over the past two years, officials said.

Entecavir is a major compound of the original drug Baraclude developed by BMS Pharmaceutical BMS제약. Baraclude added the indication for pediatric aged 2 or older in 2015. Generics have failed to insert the same indication but will reflect the same added conditions as those to the original drug.

Until Baraclude added the pediatric indication, lamivudine had been used for infants. Because Lamivudine has a high incidence of tolerance, it isn’t used for adults as the primary therapy.

The approval of the indication for children aged 2 or older was based on a comparative research of antivirus effectiveness and safety in Entecavir and the placebo for infants infected with HBeAg-positive chronic hepatitis B virus (HBV).

The analysis of childhood tolerance to be included in the approval conditions was based on the results of clinical trials of AI463028 and AI46318. The trials were for infants who became infected with HBeAg positive chronic hepatitis B virus and had not received nucleoside treatment.

The two trials provide data about resistance from 183 patients checked in the first and 180 others examined in the second year of the treatment.

The tests conducted genetic type evaluation for all patients who had a virologic breakthrough for 96 weeks or whose HBV DNA was ≥50 IU/mL in 48 weeks or 96 weeks.

The results showed there was genetic tolerance about Entecavir from two patients in two years after the treatment. The accumulated incidence rate was 1.1 percent as of the second year.

Organizations, groups, and businesses that have opinions about the unified adjustment plan can submit their views to the ministry by next Thursday.


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