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Pfizer Submits FDA Software for Emergency Approval of Covid Remedy Tablet

Pfizer filed an application with the Food and Drug Administration on Tuesday for emergency approval of its Covid-19 treatment pill, saying it would reduce hospital stays and deaths by 89% when administered with a popular HIV drug.

If the pill is approved by the FDA, it could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help ease the burden on hospital systems during the pandemic.

The pill, known as paxlovid, blocks the activity of an enzyme that the virus needs to replicate. Paxlovid is used in combination with a low dose of ritonavir, an HIV drug, to slow the patient’s metabolism down so that the drug at a higher concentration can stay active in the body for longer to fight the virus.

In a clinical study of people aged 18 and over at an increased risk of developing severe Covid, the combination of paxlovid and ritonavir reduced hospital stays and deaths by 89% when taken within three days of symptoms appearing, according to Pfizer.

Pfizer said the Covid treatment was shown to be safe, adding that study participants taking paxlovid reported fewer side effects than the placebo and that most of them were “mild intensity”.

If approved, paxlovid is given in two 150 mg tablets with one 100 mg tablet of ritonavir twice a day.

“We are working hard to get this potential treatment into patients’ hands as soon as possible and look forward to working with the US FDA to review our application as well as other regulatory agencies around the world,” said Pfizer Das said CEO Albert Bourla in a statement on Tuesday.

Bourla had previously said that Pfizer planned to file its data with the FDA before Thanksgiving.

The Biden administration is expected to announce a multibillion dollar deal this week to purchase 10 million courses of the Pfizer pill, according to the Washington Post.

Early Tuesday, Pfizer announced that it would allow generic companies to manufacture the pill through a licensing agreement with the Medicines Patent Pool, a United Nations-backed public health group. These manufacturers will supply the generic pill to 95 middle and low income countries. Pfizer will waive royalties for low-income countries and other nations covered by the treaty as long as the World Health Organization classifies Covid as a public health emergency of international concern.

Merck is also developing an antiviral pill, molnupiravir, to fight Covid. The company found in an interim analysis that the pill reduced the risk of hospitalization and death in adults with mild to moderate Covid by 50%.

Merck, which co-developed the drug with Ridgeback Biotherapeutics, filed its application for approval of the pill with the FDA last month.

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