Paxlovid
Corona tablet approved in the US – Pfizer CEO: “Changes way of treatment”
Pfizer boss Albert Bourla (r., Here with US President Joe Biden at an appointment in June) hopes for a new contribution to the fight against pandemics: The corona drug Paxlovid has now been approved in the USA
© Brendan Smialowski / AFP
The US Food and Drug Administration (FDA) issued an emergency approval for the corona drug Paxlovid from the US manufacturer Pfizer on Wednesday. Who can be treated with it and what health authorities hope for the course of the pandemic.
The corona drug Paxlovid from the US pharmaceutical giant Pfizer has been approved in the United States. The US Food and Drug Administration (FDA) granted emergency approval for the antiviral drug in pill form for high-risk patients aged twelve and over on Wednesday. US President Joe Biden pledged government support to Pfizer to quickly ramp up production of the drug.
Paxlovid is used in people at risk with mild to moderate symptoms and, according to Pfizer, lowers the risk of hospitalization or death by nearly 90 percent. The drug reduces the ability of the coronavirus to multiply in the body’s cells and thus slows down the further development of the Covid-19 disease caused by the virus.
“First treatment in the form of a pill”
“Today’s approval introduces the first treatment for Covid-19 in the form of a pill that is taken orally,” said FDA representative Patrizia Cavazzoni. “This approval brings a new tool to combat Covid-19 at a crucial point in the pandemic as new variants emerge.” Patients at high risk of a severe course of the disease would now have better access to treatment with an antiviral drug.
Pfizer chief Albert Bourla said Paxlovid will “change the way we treat Covid-19”. The drug will “hopefully” help to relieve the health system and hospitals.
President Biden said the US agency’s decision was “a testament to the power of science and the result of American innovation and ingenuity.”
Paxlovid combines the new active ingredient nirmatrelvir with the drug ritonavir, which is already used to treat HIV patients. Patients take two tablets of nirmatrelvir and one tablet of ritonavir twice a day for five days. The US government has already ordered ten million packs for a price of $ 5.3 billion.
FDA: Paxlovid is not a substitute for vaccination
The EU Medicines Agency EMA supported the use of paxlovid in emergencies last week. This means that the drug can be used before it is approved in the EU; the decision rests with the national authorities.
The US pharmaceutical company Merck Sharp & Dohme (MSD) has also developed molnupiravir, an antiviral drug against the coronavirus. According to the company, its effectiveness is only 30 percent. It has already been approved in Great Britain and Denmark. An emergency license is being examined in the USA.
Paxlovid and molnupiravir have the advantage that patients can easily take the pills at home. Other agents such as the antiviral drug Remdesivir, on the other hand, have to be administered intravenously and therefore in hospitals.
The FDA stressed on Wednesday, however, that paxlovid is not a substitute for vaccinations. Pfizer produces the corona vaccine Comirnaty together with the Mainz-based company Biontech. It is by far the most widely used corona vaccine in the USA – and also in Germany.
The government of US President Joe Biden and the country’s health authorities are trying to convince more people to have a corona vaccination – also in view of the rapid spread of the omicron variant. In the United States, only 61.6 percent of the total population have been fully vaccinated against the coronavirus so far.
Government measures to expand corona tests are also difficult to get started. There are long lines at test stations in many cities in the United States. Because of the high demand for home testing before the holidays, major retailers such as Amazon, Walgreens and CVS in the US have begun to limit the quantities they sell to customers.
On Tuesday, Biden announced the purchase of 500 million rapid tests by the federal government. However, the additional tests are not expected to be available until January.