Written By: Longjam Dineshwori | Updated : December 17, 2021 11:15 AM IST
The European Medicines Agency (EMA) has approved Pfizer's Covid-19 pill called Paxlovid for emergency use, though a formal approval is pending. On Thursday, the European Union (EU) drug regulator also issued advice on the use of the medicine for the treatment of COVID-19. Pfizer had recently announced that the pill showed near 90 per cent efficacy in preventing hospitalizations and deaths in high-risk patients, and even proved effective against the fast-spreading Omicron variant.
EMA said in a statement, "The medicine, which is not yet authorised in the EU, 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."
"Paxlovid should be administered as soon as possible after diagnosis of Covid-19 and within five days of the start of symptoms. The two active substances of the medicine, PF-07321332 and ritonavir, which are available as separate tablets, should be taken together twice a day for 5 days," it added.
EMA noted in its statement published on it website that the most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhoea and vomiting.
The drug regulator cautioned that Paxlovid must not be used with certain other medicines, the list of which is included in the proposed conditions for use. This is because "due to its action it may lead to harmful increases in their blood levels, or conversely some medicines may reduce the activity of Paxlovid itself".
EMA has warned against use of Paxlovid in patients with severely reduced kidney or liver function. The medicine is also not recommended for women who are pregnant and those who can become pregnant and who are not using contraception. Breastfeeding should be interrupted during treatment, the drug regulator said, adding that "laboratory studies in animals suggest that high doses of Paxlovid may impact the growth of the foetus."
It is an oral antiviral medicine that reduces the ability of SARS-CoV-2, the virus that causes Covid-19, to multiply in the body. The medicine comprises of two active substances, PF-07321332 and ritonavir. While PF-07321332 blocks the activity of an enzyme needed by the virus to multiply, a low dose of ritonavir (a protease inhibitor) slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus.
In its statement, EMA noted that it has issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU.
Pfizer is yet to submit a formal marketing authorisation application to the drug regulator. EMA said it will evaluate more complete data on the quality, safety and effectiveness of the medicine as they become available.
