Pfizer submits FDA application for emergency approval of Covid treatment pill

pfizer submits fda application for emergency approval of covid treatment pill

Sumary of Pfizer submits FDA application for emergency approval of Covid treatment pill:

  • The pill, if authorized by the FDA, could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral anti-viral drug at home instead of going to the hospital.
  • In a clinical trial of people 18 and over at an increased risk of developing severe Covid, the pill reduced hospitalization and death by 89% when taken within three days of the onset of symptoms, according to Pfizer.
  • Paxlovid is used in combination with a low-dose of ritonavir, an HIV drug, to slow the patient’s metabolism, allowing the drug to remain active in the body at a higher concentration for a longer period to combat the virus.
  • Pfizer said the Covid treatment proved to be safe, adding that there were fewer adverse events reported by trial participants who took Paxlovid than the placebo, and most of those were “mild in intensity.
  • “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world,” Pfizer CEO Albert Bourla said in a statement Tuesday.
  • Pfizer will wave royalty fees for low-income countries, as well as other nations covered by the agreement as long as the World Health Organization classifies Covid as a public health emergency of international concern.

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