Sovaldi's criteria for re-examination are relaxed

By Lee, Tak-Sun | translator Choi HeeYoung

21.03.16 16:09:29

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Sovaldi & Harvoni apply for mediation due to not being able to fill 3,000 cases before the end of re-examination

The Central Pharmaceutical Affairs Review Committee, reduced to 1840 cases and 798 cases, respectively, Reduction of prescriptions and reflection of inevitable circumstances such as COVID-19

It can be cured plunged 2% last year from 62% of the market share in 2017

Re-examination criteria of Sovaldi (Sofosbuvir) and Harvoni (Sofosbuvir-Ledipasvir) by Gilead Science Korea are relaxed. This is because the emergence of new drugs and the continuation of COVID-19 epidemic make it difficult to conduct sufficient usability surveys. Since the recently released hepatitis C treatment can be cured, the number of patients is decreasing.

According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee held last month decided to reduce the number of cases in the post-marketing investigation plan of Sovaldi and Harvoni. Sovaldi and Harvoni received domestic permits in the second half of 2015, and re-examination ends in September and October of this year re

Lee, Tak-Sun(hooggasi2@dailypharm.com)

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