New Drug Ronapreve Conditionally Approved By MOH As Covid Treatment

The Ministry of Health (MoH) has decided to authorise the conditional use of F. Hoffman-La Roche Ltd’s antibody cocktail Ronapreve to treat Covid-19 patients.


New Drug Ronapreve Conditionally Approved By MOH As Covid Treatment

The Ministry of Health (MoH) has decided to authorise the conditional use of F. Hoffman-La Roche Ltd’s antibody cocktail Ronapreve to treat Covid-19 patients.

Tan Sri Dr Noor Hisham Abdullah, Director-General of Health, announced in a statement today that Ronapreve would not be recommended as a substitute for Covid-19 vaccine or any other public health intervention, particularly 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.

source - berita harian

Ronapreve, which will be distributed in Malaysia by Roche (Malaysia) Sdn Bhd, will enable the treatment and prevention of Covid-19 in adults and adolescents aged 12 years and older who weigh at least 40kg and do not require supplemental oxygen, as well as an increased risk of 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 that the National Pharmaceutical Regulatory Agency accepted a clinical trial import licence for Patheon Pharmaceuticals Inc’s Covid-19 antiviral drug Molnupiravir, after 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 stated that the Ministry of Health would continue to demonstrate its commitment by increasing access to medication for the treatment or prevention of Covid-19 throughout the nation, while also ensuring that each drug is adequately tested for its quality, safety, and efficacy.

Source: The Vibes

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