[UPDATED] MoH green-lights conditional approval for Ronapreve to treat Covid-19

KUALA LUMPUR – The Health Ministry (MoH) has agreed to allow the usage of F. Hoffman-La Roche Ltd’s antibody cocktail Ronapreve on a conditional basis to treat Covid-19 patients.

In a statement today, Health Director-General Tan Sri Dr Noor Hisham Abdullah said Ronapreve will not be proposed as a replacement for Covid-19 vaccination or any public health actions, especially SOP compliance.

“The MoH would like to inform that the conditional approval is subject to information regarding the quality, safety and the efficiency of the product will be monitored and evaluated based on the latest data from time to time.

“This is to ensure the benefit of risk assessment for Ronapreve will remain positive,” he said.

Ronapreve, which will be made available in the country via Roche (Malaysia) Sdn Bhd, will allowed for the treatment and prevention of Covid-19 in adults and adolescents aged 12 years and older weighing at least 40kg and did not require supplemental oxygen, in addition to an increased risk for progression to severe Covid-19.

“In terms of prevention, Ronapreve will only be allowed for use in individuals who either have a medical condition making them unlikely to respond to or be protected by vaccination, or if they are not vaccinated against Covid-19.”

Additionally, Dr Noor Hisham said, the National Pharmaceutical Regulatory Agency has also approved a clinical trial import licence for Covid-19 antiviral medication Molnupiravir, manufactured by Patheon Pharmaceuticals Inc, following an application by Mareck Sharp & Dohme (Malaysia) Sdn Bhd.

“The third-phase clinical studies will be conducted at two research centres in the country, with a target number of subjects to be tested set for 20 people aged 18 and above.

“The study is expected to take nine months and will be part of the global research conducted by several countries,” he said.

Dr Noor Hisham added that MoH will continue to show its commitment by expanding its access to medicine for the purpose of treatment or prevention of Covid-19 in the country by ensuring that each drug is evaluated properly based on its quality, safety and efficiency. – The Vibes, December 14, 2021