DCA grants conditional registration for Ravida tablets

 

The Drug Control Authority (DCA) Malaysia has granted conditional registration for Ravida Tablet 200 milligram (Ravidasvir Hydrochloride 200mg) at its 358th meeting held today, said Health director-general Dr Noor Hisham Abdullah.

He said 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.

According to Noor Hisham, the product is manufactured by the Doppel Farmaceutici S.R.L, Italy, with Pharmaniaga Manufacturing Bhd 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,” he said in a statement today.

Noor Hisham said the National Strategic Plan for Hepatitis B & C 2019-2023 was developed by the Ministry of Health (MOH) to clearly strategise and to ensure the goal to eliminate hepatitis B and C is achievable.

Hence, he said 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 sites in Malaysia and four 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 April 15, 2021,” he said.

He also mentioned that the 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.

- Bernama