Europe OKs 1st 1-dose drug against RSV
LONDON, Nov 5, (AP): The European Commission has authorized the world’s first one-dose drug against a respiratory virus that sickens millions of babies and children globally every year.
In a statement Friday, drugmakers Sanofi and AstraZeneca said the European Commission had given the green light to nirsevimab, a laboratory-developed antibody designed to protect infants during their first exposure to RSV, or respiratory syncytial virus, a highly contagious common infection that infects nearly all babies by age 2.
At the moment, babies at high risk of the disease can be given monthly shots to protect them during RSV season.
In September, the European Medicines Agency recommended that nirsevimab, sold as Beyfortus, be authorized based on advanced research that showed the drug reduced the chances that babies with RSV needed medical attention and appeared to be safe, compared to infants who got a dummy treatment. The drug is given in a single injection.
“We are excited about the opportunity to expand prevention efforts to all infants,” said Silke Mader, co-founder of the European Foundation for the Care of Newborn Infants.
In the US, RSV is causing an early surge of infections in children’s hospitals this year. European health officials are warning there could be a similar spike across the continent.
For most healthy people, RSV is a cold-like nuisance. But the virus can be life-threatening for the very young and the elderly. The virus can infect deep in the lungs and in small babies, it can impede breathing by inflaming their tiny airways.
RSV kills about 100,000 babies annually, mostly in developing countries.
Nirsevimab was developed to give newborns and infants immediate protection against RSV through an antibody to prevent infections in their respiratory systems.
Earlier this week, Pfizer announced preliminary research showing that a new vaccine given to pregnant women could help protect their babies against RSV, after decades of failure to devel
op an effective shot.
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NEW YORK: The nation’s top public health agency on Thursday softened its guidelines for US doctors prescribing oxycodone and other opioid painkillers.
The Centers for Disease Control and Prevention new recommendations are an update to 2016 guidelines that added momentum to a decline in opioid painkiller prescriptions.
Opioids painkillers can be addictive - even when used under doctors’ orders - and were identified as a big reason for a rise in US drug overdoses that began more than two decades ago. Other drugs have overtaken them in overdose statistics, and illicit fentanyl is now the biggest driver of deaths.
The previous guidance succeeded in reducing inappropriate and dangerous prescribing, some experts say. But they also were seen as a barrier to care,
with some pharmacists refusing to fill prescriptions as doctors wrote them.
The new guidelines are designed to ensure that patients get compassionate and safe pain care, CDC officials said.
A draft released in February received 5,500 public comments. Some modifications were made, but several main changes stayed in place, including:
■ The CDC no longer suggests trying to limit opioid treatment for acute pain to three days.
■ The agency is dropping the specific recommendation that doctors avoid increasing dosage to a level equivalent to 90 milligrams of morphine per day.
■ For patients receiving higher doses of opioids, the CDC is urging doctors to not abruptly halt treatment unless there are indications of a lifethreatening danger. The agency offers suggestions on tapering patients off the drugs.