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Emergency use of Paxlovid allowed in Europe

The EMA has issued advice to member states on potentially pre-approval use of Pfizer’s anti-COVID-19 treatment Paxlovid while a rolling review of data is ongoing

The Committee for Medicinal Products for Human Use (CHMP) which advises the European Medicines Agency (EMA) has issued advice on the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19 while the EMA reviews data on the therapy.

The advice was issued to support the European Union’s national authorities who may wish to allow early, emergency use of the therapy ‘in light of the rising rates of infection and deaths due to COVID-19’ across the region.

Under the advice, Paxlovid can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The therapy should be administered as soon as possible after diagnosis and within five days of the start of symptoms.

Paxlovid is an orally administered, investigational SARS-CoV-2 protease inhibitor antiviral therapy. It is a combination of Pfizer’s nirmatrelvir (PF-07321332) – which is designed to block the activity of the 3CL protease that the coronavirus needs to replicate – and antiretroviral ritonavir, which helps slow the metabolism of nirmatrelvir.

Trial data on the therapy show that it cuts the risk of hospitalisation or death from COVID-19 by 89%. However, Paxlovid may be an even more powerful weapon in the fight against the pandemic than the already robust data suggest due to its potential action against the Omicron variant of concern.

“Current variants of concern can be resistant to treatments that are focused on the spike protein expressed on the surface of the SARS-CoV-2 virus, due to the mutations in this region. Paxlovid, however, works intracellularly on the protease of the SARS-CoV-2 virus by inhibiting viral replication,” said Pfizer.

The company added that nirmatrelvir had shown ‘consistent in vitro antiviral activity’ against all the previously identified variants of concerns (alpha, beta, delta, gamma, lambda, and mu), and ‘potently inhibited the 3CL protease associated with Omicron’ in an in vitro biochemical assay.

‘This indicates nirmatrelvir’s potential to maintain robust antiviral activity against Omicron’, it concluded.

The EMA also announced that it has started a ‘comprehensive rolling review’ ahead of a possible application for a marketing authorisation by Pfizer.

In late November 2021, only days after Pfizer applied for an emergency use authorisation, it signed a $5.3bn deal with the US government for 10 million treatment courses of Paxlovid. The company has also inked advance purchase agreements with several other countries, although it is also committed to providing the therapy at an affordable price for poorer countries.

Article by
Hugh Gosling

17th December 2021

From: Healthcare

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