Pfizer Seeks FDA Emergency Approval For Its Covid Antiviral Pill Paxlovid

source – cnbc
  • Pfizer’s Paxlovid has demonstrated to ability to reduce the risk of hospital and desk in individuals at high risk of severe disease by 89%.

  • Pfizer is currently only seeking FDA emergency approval for Paxlovid to be utilised in unvaccinated individuals as vaccinated individuals were not included in clinical trials.

Pfizer Seeks FDA Emergency Approval For Its Covid Antiviral Pill Paxlovid

Pfizer requested approval from the Food and Drug Administration on Tuesday for Paxlovid, an experimental Covid-19 antiviral treatment.

The medication has been demonstrated in clinical studies to significantly reduce the risk of hospitalisation and death in people at high risk of severe disease by 89%, the company said this month, although the full data set has not been made public for review by scientists.

According to experts, an antiviral pill for Covid would have a significant impact on the coronavirus pandemic by allowing for treatment at home without the need for injections or IVs.

Pfizer’s treatment consists of three tablets administered twice daily for five days. It is intended to be administered as soon as possible, between three to five days after the onset of symptoms.

According to Jerica Pitts, a Pfizer spokesperson, the company sought authorisation for the treatment exclusively for unvaccinated individuals at this moment. Vaccinated individuals were excluded from the trial, she said. Vaccinated individuals, including those with an underlying medical condition, are now enrolled in further studies, Pfizer said in a separate email. Eventually, such data will be shared with authorities, but the FDA and CDC will determine how the medications are labeled for usage.

In September, another trial began implementing the antiviral treatment to prevent Covid in individuals who share a home with someone who has a diagnosed symptomatic covid-19 infection.

Paxlovid functions by inhibiting the coronavirus from replicating inside cells. It combines two antivirals: an experimental compound named PF-07321332 and ritonavir, which is currently used to treat HIV.

source - business recorder

According to Pfizer, the medication is safe and associated with mild side effects that arose at the same rate as in the placebo group. It did not specify these side effects.

Pfizer stated on Tuesday that it had reached an agreement with a United Nations-backed initiative to enable other pharmaceutical companies to manufacture the pill, potentially making it easily accessible to more than half of the world’s population.

Pfizer is not the first company to apply to the FDA for approval of an antiviral tablet for Covid; Merck and its partner, Ridgeback Biotherapeutics, submitted an application in October for its own covid antiviral pill, Molnupiravir. An advisory committee will meet to review Pfizer’s request on Nov 30.

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