Germany hopes for emergency approval of Covid-19 tablet in January
Germany wants to get approval for Pfizer's Paxlovid oral Covid-19 drug in January, Health Minister Karl Lauterbach told media.
Speaking to Welt am Sonntag, Lauterbach said "I am confident that we will have put together the necessary package for this by the end of this month so that we will receive deliveries of the drug and get emergency approval".
Germany's Institute for Drugs and Medical Devices (BfArM) is currently working on national approval for the drug so that Germany can use it even before the European Medicines Agency (EMA) gives its approval, which is still pending.
"The drug is particularly suitable for treating unvaccinated at-risk patients," said Lauterbach, adding that this was a large group.
Germany's Ministry of Health said at the start of last week that it had already secured one million units of the drug from Pfizer and had optioned delivery of a further million units.
At that time, Lauterbach explained that he saw oral drug treatment as a significant step towards ending the pandemic: "With a combination of increasingly effective vaccines and treatment options, Covid is becoming a disease that will lose its terror".
Paxlovid is an antiviral that prevents the Covid-19 virus from reproducing. It does this by blocking an enzyme the virus needs to multiply.
It has not yet been approved in the EU, but the EMA supports its use in emergencies.
The US drug agency FDA gave emergency approval for its use in high-risk patients over 12 just before Christmas and two days ago, UK medicines regulator MHRA approved its use in over-18s with at least one risk factor for developing serious disease.
According to Pfizer, the pills have been very successful in preventing severe disease progression in high-risk patients: an interim analysis of test results showed that the drug reduced the risk of hospitalisation and death in Covid-19 patients by 89 percent.
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Speaking to Welt am Sonntag, Lauterbach said "I am confident that we will have put together the necessary package for this by the end of this month so that we will receive deliveries of the drug and get emergency approval".
Germany's Institute for Drugs and Medical Devices (BfArM) is currently working on national approval for the drug so that Germany can use it even before the European Medicines Agency (EMA) gives its approval, which is still pending.
"The drug is particularly suitable for treating unvaccinated at-risk patients," said Lauterbach, adding that this was a large group.
Germany's Ministry of Health said at the start of last week that it had already secured one million units of the drug from Pfizer and had optioned delivery of a further million units.
At that time, Lauterbach explained that he saw oral drug treatment as a significant step towards ending the pandemic: "With a combination of increasingly effective vaccines and treatment options, Covid is becoming a disease that will lose its terror".
Paxlovid is an antiviral that prevents the Covid-19 virus from reproducing. It does this by blocking an enzyme the virus needs to multiply.
It has not yet been approved in the EU, but the EMA supports its use in emergencies.
The US drug agency FDA gave emergency approval for its use in high-risk patients over 12 just before Christmas and two days ago, UK medicines regulator MHRA approved its use in over-18s with at least one risk factor for developing serious disease.
According to Pfizer, the pills have been very successful in preventing severe disease progression in high-risk patients: an interim analysis of test results showed that the drug reduced the risk of hospitalisation and death in Covid-19 patients by 89 percent.
READ ALSO:
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