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Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says

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Paxlovid is a Pfizer pill that fights the coronavirus (COVID-19). This undated handout photo was taken by Reuters November 16, 2021.

via Reuters| Handout | via Reuters

CNBC was told Wednesday by CEO Albert Bourla that Pfizer will provide all information on the Covid pill’s treatment to the Food and Drug Administration within the next days.

Bourla indicated that he was confident in the final results of the clinical trials, which will reveal whether Paxlovid (oral antiviral pill) reduces deaths and hospitalizations by 89%. This is consistent with interim data, which were revealed in November. Paxlovid may be combined with popular HIV drugs, such as ritonavir.

Bourla stated that the complete set will be available within a matter of days.Squawk Box.” They will be submitted. The data we submit should be similar to what was seen in the initial part of this study. It is unlikely that we’ll see any difference once we have unblinded the data.

Pfizer filed its emergency application last month to FDA seeking approval for the treatment. Bourla said that the FDA is feeling a lot of urgency, and they are likely to make a decision by this month.

Bourla indicated that the FDA will approve the product soon and the pills would be made available for purchase. CNBC was informed by the CEO that they have shipped the product already into America. The product should be on the market in the next month, if approval is granted.

President Joe BidenLast month, it was reported that the U.S. purchased 10 million Paxlovid courses and deliveries will begin at the end.

Bourla had previously stated to CNBC that the effectiveness of the Pill will not be affected by omicron because the drug works in a different way than vaccines. Paxlovid stops the virus from reproducing by blocking an enzyme, which is different than vaccines that target spike proteins.

Spike protein mutations have been seen in many virus types, increasing its transmissibility and sometimes causing more serious complications. The type of mutation that causes the spike could require updates to vaccines.

Bourla said that the virus can’t mutate without the enzyme called a protease that Pfizer targets in its pill targets.

Bourla stated that it is very hard for the virus create a strain without protease. It’s possible. It’s not impossible.

FDA advisory panel narrowly endorsed Merck and Ridgeback Therapeutics’ oral antiviral pill, molnupiravir, late last month. Members of the panel were split and concerned about unanswered concerns regarding safety and efficacy of molnupiravir.

Merck’s interim results showed that the pill is 50% effective in preventing death and hospitalization, while fuller data shows it to be only 30%.

Many FDA advisory panel members said that the FDA should reconsider withdrawing Merck’s emergency authorization for Merck if the FDA finds another option. Molnupiravir has yet to be approved by the FDA.

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