KUALA LUMPUR, Dec 14 — Health director-general Tan Sri Dr Noor Hisham Abdullah today said that Ronapreve, a Swiss-made medicine for the treatment and prevention of Covid-19, has received conditional approval from the Health Ministry.
He said the 367th Drug Control Authority (DCA) meeting decided to give conditional approval to use the Ronapreve Solution for injection or infusion as a treatment for Covid-19.
In a statement this morning, Dr Noor Hisham said Ronapreve Solution, developed by Roche (Malaysia) Sdn. Bhd. and manufactured by F.Hoffman-La Roche Ltd, Switzerland contains the active ingredients Casirivimab and Imdevimab and would be used to treat those facing a high risk of severe Covid-19 infection.
He said Ronapreve can be used for the treatment of Covid-19 in adults and adolescents aged 12 years’ old and above, weighing at least 40kg and who do not require supplemental oxygen and who are at risk of progressing to severe Covid-19.
He said the drug can also be used for prevention.
"Ronapreve is indicated for the prevention of Covid-19 in adults and adolescents aged 12 years and older and weighing at least 40 kg who have been exposed or 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.
Dr Noor Hisham stressed that Ronapreve is not meant to be used as a replacement for Covid-19 vaccines.
“The Health Ministry wishes to state that the conditional approval is subject to periodic monitoring on quality, safety and efficacy and evaluation of the latest data.
“This is to ensure the benefit over risk for Ronapreve remains positive.”
Meanwhile Dr Noor Hisham also said the National Pharmaceutical Regulatory Agency (NPRA) has granted Merck Sharp & Dohme (Malaysia) Sdn Bhd and Patheon Pharmaceuticals Inc (US) a clinical trial import license for Molnupiravir, a drug to prevent Covid-19.
He said phase three clinical trials for the drug will be carried out over a period of nine months.
He added that the trials will involve 20 people above the age of 18.