US FDA approves 1st oral pill by Pfizer to treat Covid-19

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 Covid19 along with caution for people with certain preexisting conditions heralding a new era for the future overthecounter treatment of the deadly respiratory disease that has killed millionsPfizers Paxlovid nirmatrelvir tablets and ritonavir tablets copackaged for oral use has been approved for the treatment of mildtomoderate coronavirus disease Covid19 in adults and paediatric patients 12 years of age and older weighing at least 40 kg with positive results of direct SARSCoV2 testingThe pill has also been approved for those at high risk for progression to severe Covid19 including hospitalisation or deathPaxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of Covid19 and within five days of symptom onset the FDA said in a statement late on WednesdayThe authorisation introduces the first treatment for Covid19 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 FDAs Center for Drug Evaluation and ResearchThis authorisation provides a new tool to combat Covid19 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 Covid19 Cavazzoni addedPaxlovid is not authorised for the preexposure or postexposure prevention of Covid or for initiation of treatment in those requiring hospitalisation due to severe or critical Covid19The pill is also not a substitute for vaccination in individuals for whom Covid19 vaccination and a booster dose are recommendedPaxlovid consists of nirmatrelvir which inhibits a SARSCoV2 protein to stop the virus from replicating and ritonavir which slows down nirmatrelvirs breakdown to help it remain in the body for a longer period at higher concentrationsPaxlovid 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 daysThe primary data supporting this EUA for Paxlovid are from EPICHR a randomised placebocontrolled clinical trial studying Paxlovid for the treatment of nonhospitalised symptomatic adults with a laboratory confirmed diagnosis of SARSCoV2 infectionPatients 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 conditionsPossible sideeffects 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 saidUsing Paxlovid in people with uncontrolled or undiagnosed HIV1 infection may lead to HIV1 drug resistance Ritonavir may cause liver damage so caution should be exercised when giving Paxlovid to patients with preexisting liver diseases liver enzyme abnormalities or liver inflammation the FDA warnedAlso Read UK registers 106122 new Covid19 infections highest since pandemic beganThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever