WELLINGTON: New Zealand’s medicine regulator on Tuesday approved a new COVID-19 medicine Ronapreve, which can both prevent and treat COVID-19 though it is not a substitute for vaccination and its effectiveness against the Omicron variant is yet to be demonstrated.
Ronapreve is a monoclonal antibody drug that mimics the body’s natural defenses for fighting disease, Chris James, group manager at the health ministry’s medicine regulatory arm Medsafe, said in a statement.
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, James said.
Ronapreve is approved for the treatment of COVID-19 for people who are badly affected by the virus and who are at increased risk of progressing to severe COVID-19 disease, he said.
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, he added.
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, James said, adding that Ronapreve is not approved for use in children.
Tuesday’s announcement is a significant advance in providing an additional tool to health professionals that allows them to both saving lives and taking pressure off the hospitals, allowing them to focus on treating people with other conditions, he said.
Ronapreve is known to be effective against the Delta variant and research is now focusing on its effectiveness against the Omicron variant, he said, adding that Medsafe will continue to evaluate that information when it becomes available.
In late October, New Zealand announced that Pharmac, the national medicine-buying agency, had already secured access to enough doses of Ronapreve 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 people and hospital services against the worst impacts of the COVID-19 pandemic.
Ronapreve is the first new drug to get Medsafe’s approval, he said, adding 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.
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