Green light in the EU for Pfizer’s anti-Covid pill. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has recommended granting conditional marketing authorization for the antiviral pill Paxlovid * (PF-07321332 / ritonavir) in the treatment of infected adults from Sars-CoV-2, which do not require supplemental oxygen and have an increased risk of developing severe disease. The regulatory body communicates this in a note. The verdict arrived, as expected, within this week, at the end of the three-day meeting of the CHMP. Paxlovid is the first oral antiviral for Covid recommended in the EU, having concluded its process before the one still underway for the other anti-Covid pill, Merck’s molnupiravir (MSD outside the US and Canada), a drug already in use in Italy. Paxlovid contains two active substances – PF-07321332 and ritonavir – in two different tablets. PF-07321332 works by reducing the ability of the coronavirus Sars-CoV-2 to replicate while ritonavir prolongs the action of PF-07321332 allowing it to stay longer in the body at levels that affect the multiplication of the virus. To arrive at today’s verdict, the CHMP evaluated data from a study in which treatment with Paxlovid significantly reduced hospitalizations or deaths in Covid patients with at least one pre-existing disease that puts them at risk of developing a severe form. PF-07321332 works by reducing the ability of the coronavirus Sars-CoV-2 to replicate while ritonavir prolongs the action of PF-07321332 allowing it to stay longer in the body at levels that affect the multiplication of the virus. To arrive at today’s verdict, the CHMP evaluated data from a study in which treatment with Paxlovid significantly reduced hospitalizations or deaths in Covid patients with at least one pre-existing disease that puts them at risk of developing a severe form. PF-07321332 works by reducing the ability of the coronavirus Sars-CoV-2 to replicate while ritonavir prolongs the action of PF-07321332 allowing it to stay longer in the body at levels that affect the multiplication of the virus. To arrive at today’s verdict, the CHMP evaluated data from a study in which treatment with Paxlovid significantly reduced hospitalizations or deaths in Covid patients with at least one pre-existing disease that puts them at risk of developing a severe form.

Pxlovid study: a placebo within 5 days of Covid symptoms

People enrolled in the study received Paxlovid or a placebo within 5 days of the onset of Covid symptoms. In the month following treatment, 0.8% (8 out of 1,039) of those treated with Paxlovid were hospitalized for more than 24 hours, compared with 6.3% (66 out of 1,046) of those who received placebo. There were no deaths in the Paxlovid group, while there were 9 in the placebo group. Most of the patients involved in the trial were infected with the Delta variant. But “based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” explains the EMA. The safety profile of the drug was “favorable and side effects were generally mild. However – adds the EU agency – it is known that ritonavir influences the action of many other medicines “and, in consideration of this, advice and warnings have been “included in the Paxlovid product information. The company has also provided a tool on its website that can be accessed via a QR code included in the product information and on the outer packaging ”. “A letter will also be sent to the relevant health care organizations to further remind them of the problem” of interactions with other drugs. The CHMP therefore concluded that the medicine’s benefits for approved use outweigh its risks. Now these recommendations will be sent to the European Commission for a quick decision applicable in all EU member states. The company has also provided a tool on its website that can be accessed via a QR code included in the product information and on the outer packaging ”. “A letter will also be sent to the relevant health care organizations to further remind them of the problem” of interactions with other drugs. The CHMP therefore concluded that the medicine’s benefits for approved use outweigh its risks. Now these recommendations will be sent to the European Commission for a quick decision applicable in all EU member states. The company has also provided a tool on its website that can be accessed via a QR code included in the product information and on the outer packaging ”. “A letter will also be sent to the relevant health care organizations to further remind them of the problem” of interactions with other drugs. The CHMP therefore concluded that the medicine’s benefits for approved use outweigh its risks. Now these recommendations will be sent to the European Commission for a quick decision applicable in all EU member states. “A letter will also be sent to the relevant health care organizations to further remind them of the problem” of interactions with other drugs. The CHMP therefore concluded that the medicine’s benefits for approved use outweigh its risks. Now these recommendations will be sent to the European Commission for a quick decision applicable in all EU member states. “A letter will also be sent to the relevant health care organizations to further remind them of the problem” of interactions with other drugs. The CHMP therefore concluded that the medicine’s benefits for approved use outweigh its risks. Now these recommendations will be sent to the European Commission for a quick decision applicable in all EU member states.

Anti Covid pill: up to 120 million Paxlovid cycles by the end of 2022

Up to 120 million anti-Covid treatment cycles with the Paxlovid * pill (nirmatrelvir / ritonavir) will be made available globally by Pfizer by the end of 2022, thanks to continued investments to support the production and distribution of the drug. “An expression of confidence that comes at a critical moment in which Europe faces the current challenges of the pandemic and in which infection rates are increasing in many countries around the world”, comments Albert Bourla, president and CEO of the group. “We are proud to have a strong manufacturing presence in Europe, which will help produce up to 120 million Paxlovid cycles globally”, adds the manager who ensures: