December 23, 2021
3 mins read

US nod for Pfizer’s Covid oral pill

The pill has also been approved for those at high risk for progression to severe Covid-19, including hospitalisation or death….reports Asian Lite News

 As Omicron variant spreads globally, the US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the Pfizer antiviral pill to treat Covid-19 along with caution for people with certain pre-existing conditions — heralding a new era for the future, over-the-counter treatment of the deadly respiratory disease that has killed millions.

Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved for the treatment of mild-to-moderate coronavirus disease (Covid-19) in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 testing.

The pill has also been approved for those at high risk for progression to severe Covid-19, including hospitalisation or death.

Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset, the FDA said in a statement late on Wednesday.

“The authorisation introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

“This authorisation provides a new tool to combat Covid-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe Covid-19,” Cavazzoni added.

Paxlovid is not authorised for the pre-exposure or post-exposure prevention of Covid or for initiation of treatment in those requiring hospitalisation due to severe or critical Covid-19.

The pill is also not a substitute for vaccination in individuals for whom Covid-19 vaccination and a booster dose are recommended.

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.

Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.

The pill is not authorised for use for longer than five consecutive days.

The primary data supporting this EUA for Paxlovid are from EPIC-HR, a randomised, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalised symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.

Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions.

“Possible side-effects of Paxlovid include impaired sense of taste, diarrhoea, high blood pressure and muscle aches. Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions,” the FDA said.

Using Paxlovid in people with uncontrolled or undiagnosed HIV-1 infection may lead to HIV-1 drug resistance.

“Ritonavir may cause liver damage, so caution should be exercised when giving Paxlovid to patients with pre-existing liver diseases, liver enzyme abnormalities or liver inflammation,” the FDA warned.

ALSO READ: EMA recommends emergency use of Pfizer Covid-19 pill

Previous Story

Italy meets EU recovery fund targets, govt ready to keep supporting economy: PM

Next Story

Intel Move on Uyghur Products Annoys China

Latest from -Top News

Trump due in Saudi, UAE amid new tariffs

The GCC bloc, which includes the UAE, Saudi Arabia, Oman, Kuwait, Qatar, and Bahrain, has been hit with a 10% tariff, placing them among the lower-tiered rates US President Donald Trump has

China Says US Tariff Hikes Violate WTO Rules

China is among the hardest-hit, facing a 34 per cent levy—part of what Washington describes as reciprocal measures aimed at rebalancing trade deficits and curbing unfair trade practices China has strongly condemned

Modi Due in Sri Lanka to Cement Ties

Indian High Commissioner to Sri Lanka Santosh Jha described the visit to island nation as “very important” and likely will set a fresh agenda for bilateral cooperation Prime Minister Narendra Modi’s visit

India Acts as ‘First Responder’ in Myanmar: Jaishankar

Jaishankar took the opportunity to underscore India’s swift humanitarian response, highlighting Operation Brahma, which was launched to assist those affected by the earthquake. External Affairs Minister S. Jaishankar on Thursday expressed India’s
Go toTop

Don't Miss

US Court blocks Texas from implementing immigration law

Opponents have called the law the most dramatic attempt by

US intel suggests Putin may not have ordered Navalny death

Among those facts was the timing of the opposition leader’s