The Ministry of Food and Drug Safety (MFDS) has approved Besivo Tab. (compound: besifovir), a chronic hepatitis B therapy developed by Ildong Pharmaceutical일동제약. It is the 28th new drug made by Korean pharmaceutical companies and Ildong’s first.
Besivo Tab. is also the first chronic hepatitis B therapy of nucleotide series developed by the domestic drugmaker, and the second new drug for hepatitis
B, following Levovir Cap. of Bukwang Pharm 부광약품 approved in November 2006.
|Ildong Pharmaceutical’s headquarter office in Yangjae-dong, southern Seoul|
Besivo Tab. has proved noninferiority compared with Gilead’s Viread (compound: tenofovir) in Phase 3 clinical trials conducted on chronic hepatitis B patients in 28 university hospitals who had not got treatments before. After a 48-week treatment, Besivo Tab. showed noninferiority in virus response (HBV DNA < 400 copies/mL) compared with Viread. There were no patients who showed resistance to Besivo, either.
According to Ildong, Besivo Tab. showed superior results in bone mineral density, kidney toxicity, and histological response.
Besivo Tab. is the first new drug of Ildong Pharmaceutical. LG Chemical (formerly LG Life Sciences) produced a candidate substance in the early 2000s and finished Phase 2 clinical trial. Ildong made a license contract in 2012, introduced besifovir from LG Chemical, formed a task force of working-group officials from the two companies, and have jointly developed it.
Ildong began Phase 3 trial in 2013, completed it in 2016, and applied to the ministry for its approval later in the year.
Ildong confirmed the treatment effect of hepatitis B virus resistant to lamivudine compound, and little kidney toxicity and other side effects through clinical trials, and is expecting the new drug would replace it.
Ildong plans to release Besivo Tab. in the second half of this year. Currently, Viread made by Gilead is No.1 in the chronic hepatitis B therapy market. The company will promote advantages of its new drug, emphasizing it is not inferior in treatment efficacy and few side effects such as the reduction bone mineral density and kidney toxicity. As Ildong also has export to the Southeast Asian market in mind, the company will likely concentrate on the drug’s significant advantages in conducting PR activities.
<© Korea Biomedical Review, All rights reserved.>