Conditional approval given for antibody Covid treatment

The health ministry has given conditional registration approval for use of the Ronapreve solution for injection or infusion in the treatment and prevention of Covid-19 in the country.

Health director-general Dr Noor Hisham Abdullah said the matter was approved at the 367th Drug Control Authority meeting yesterday.

However, he said the Ronapreve product is not intended to be used as a substitute for Covid-19 vaccination.

“Ronapreve is indicated for the treatment of Covid-19 in adults and adolescents aged 12 years and older and weighing at least 40kg who do not require supplemental oxygen for Covid-19 and who are at increased risk of progressing to severe Covid-19.

“On prevention, Ronapreve is indicated for the prevention of Covid-19 in adults and adolescents aged 12 years and older and weighing at least 40kg who have been exposed or are at high risk of exposure to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or be protected by vaccination or are not vaccinated against Covid-19,” he said in a statement today.

He said the conditional registration approval required information on the quality, safety and effectiveness of the product to be monitored and evaluated based on the latest data from time to time, to ensure the benefit over risk comparison for Ronapreve remains positive.

The registration holder for the Ronapreve product, which contains the active ingredients Casirivimab and Imdevimab at a strength of 120mg/ml, is Roche (Malaysia) Sdn Bhd. It is manufactured by F Hoffman-La Roche Ltd, Switzerland.

Meanwhile, Noor Hisham said the National Pharmaceutical Regulatory Agency has approved the application for a clinical trial import licence (CTIL) for the MK-4482 200mg capsule (Molnupiravir), which is a Covid-19 prevention product.

Phase Three of the clinical study will be conducted at two research centres in Malaysia involving 20 people aged 18 and above, he said, adding that this is expected to take nine months and is part of a study conducted globally involving various countries.

The CFTIL for the product, which is manufactured by Patheon Pharmaceuticals Inc in the US, was applied for by Merck Sharp & Dohme (Malaysia) Sdn Bhd.