Tuesday, June 18, 2024

COVID drug gets Medsafe approval

Medsafe has approved a new COVID-19 medicine, Ronapreve, that can both prevent and treat COVID-19 but is not a substitute for vaccination, the Ministry of Health has announced.

The Ministry said the drug’s effectiveness against the latest Omicron variant of concern is also yet to be demonstrated.

Ronapreve is a monoclonal antibody drug that mimics the body’s natural defences for fighting disease. The clinical advice is that it is a significant advance, because it reduces the severity of COVID-19 by keeping more cases out of hospital and shortens the duration of symptoms and infectious period which in turn reduces the risk of patients passing the virus on to other people, says Medsafe Group Manager, Chris James.

Ronapreve is approved for the treatment of COVID-19 for people who are badly affected by COVID-19 and who are at increased risk of progressing to severe COVID-19 disease.  

The medicine is also approved for preventing COVID-19 for people who have been exposed to the virus and have a medical condition that makes them unlikely to be protected by vaccination.

This group includes people with compromised immune systems such as individuals with cancer, transplant recipients and those with immunodeficiency disorders. These individuals are often susceptible to infections and respond poorly to vaccination.

Ronapreve is not approved for use in children. It was approved for use in Japan on August 15, closely followed the United Kingdom, which approved its use five days later. Australia purchased 15,000 doses in October, when it introduced the drug into its hospitals.

Mr James says the announcement is a significant advance, in providing an additional tool to health professionals that allows them to both saving lives and taking pressure off hospitals, allowing them to focus on treating people with other conditions. 

Ronapreve is known to be effective against the Delta variant and research is now focusing on its effectiveness against the Omicron variant. Medsafe will continue to evaluate that information when it becomes available, the Ministry said in a statement.

In late October this year, the Government announced that Pharmac, the national medicine-buying agency, had already secured access to enough doses of Ronapreve to be able to treat 5,300 people and expects to be able to buy more next year.

Ronapreve, along with four other drugs including molnupiravir, have been selected for fast tracked approval to help protect against the COVID-19 pandemic, protecting people and hospital services against its worst impacts.

Ronapreve is the first new drug to get Medsafe’s approval. Dexamethasone, an existing steroid treatment, has also been approved for treatment of COVID-19 as it helps limit the body’s over-reaction to COVID-19 seen in severe cases of infection.

“These medicines are important tools to have in our toolbox for addressing COVID-19. Other actions continue to be just as important as they have ever been. Our focus remains on getting as many people as possible vaccinated, including booster shots, and practical measures like wearing facemasks, social distancing and scanning into any locations visited,” the health ministry said.

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