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Malaysia grants conditional registration for effective hepatitis C treatment

08 July 2021 | News

New drug ravidasvir is the first HCV drug to be developed through South-South collaboration and with support from non-profit organizations

image credit- shutterstock

image credit- shutterstock

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has granted a conditional registration for a safe, effective hepatitis C treatment developed by a public-private partnership bringing together the Malaysian Ministry of Health, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), Egyptian pharmaceutical company Pharco, Malaysian pharmaceutical company Pharmaniaga Berhad, and non-governmental-organization Médecins Sans Frontières/Doctors Without Borders (MSF).

This is the very first drug for HCV to be developed through South-South collaboration and with funding and clinical support from non-profit organizations.

This partnership was formed to address one of the more intractable public health challenges of the past decade: the lack of access to affordable direct-acting antivirals (DAAs), a newer generation of powerful HCV treatments that can cure patients in three to six months. 

The approval concerns a new drug, ravidasvir, for the treatment of chronic HCV infection in adults in combination with other medicinal products. Ravidasvir was developed by the partnership for use with sofosbuvir, an existing DAA, as an affordable, simple, and efficacious public health tool.

Ravidasvir is an oral NS5A inhibitor discovered and owned by Presidio Pharmaceuticals. It was licensed to Egyptian drug manufacturer Pharco Pharmaceuticals and DNDi for clinical development and commercialization.

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