KUALA LUMPUR, June 4 (Bernama) -- The Ministry of Health (MOH) would like to inform that the Drug Control Authority (DCA) Malaysia has granted a conditional registration for Ravida® Tablet 200mg (Ravidasvir Hydrochloride 200mg) in their 358th meeting on 4th June 2021. Malaysia is the first country in the world to approve the use of Ravida®, which is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. The product is manufactured by the Doppel Farmaceutici S.R.L, Italy with Pharmaniaga Manufacturing Berhad as the product registration holder in Malaysia.
 
HCV infection is considered as a public health issue whereby Malaysia is committed to the goal to eliminate HCV by 2030. However, the cost of screening and the currently available Direct Acting Antivirals (DAAs) are expensive and there is a need to search for alternative treatments and solutions. The National Strategic Plan for Hepatitis B & C 2019-2023 was developed by MOH to clearly strategise and to ensure the goal to eliminate hepatitis B and C is achievable.

Together with the Drugs for Neglected Diseases initiative (DNDi), MOH started a collaborative endeavour in 2016 to reduce the barriers in terms of access and affordability for HCV patients in Malaysia. The primary outcome of this collaboration is the DNDi’s HCV Clinical Trial which is the STORM-C-1, conducted across six (6) sites in Malaysia and four (4) sites in Thailand. The STORM-C-1 is the pivotal trial for the product registration application and was published in ‘The Lancet Gastroenterology & Hepatology’ journal on 15th April 2021.
 
MOH would like to inform that this conditional registration approval requires the product registration holder to submit additional and up-to-date data on the product from time to time to ensure its efficacy and safety remain updated and the benefit outweighs the risk.
 
TAN SRI DATO’ SERI DR. NOOR HISHAM ABDULLAH
DIRECTOR GENERAL OF HEALTH, MALAYSIA
4 JUNE 2021

Source: Ministry of Health (MOH)

FOR MORE INFORMATION, PLEASE CONTACT:
Name: FARAHDILA WATI BINTI MOHD KHAMDE KHUZAINI
Pegawai Perhubungan Awam
Unit Komunikasi Korporat
Kementerian Kesihatan Malaysia
Tel : 03-88833470 

--BERNAMA