Dec 31 (Reuters) - UK's Medicines and Healthcare Products Regulatory Agency:

• ORAL COVID-19 ANTIVIRAL, PAXLOVID, APPROVED BY UK REGULATOR

• NEW COMBINATION TREATMENT IS FOR PEOPLE WITH MILD TO MODERATE COVID-19 WHO ARE AT HIGH RISK OF DEVELOPING SEVERE COVID-19

• TOO EARLY TO KNOW WHETHER OMICRON VARIANT HAS ANY IMPACT ON PAXLOVID'S EFFECTIVENESS

• NUMBER OF HOSPITALISATIONS AND DEATHS WERE 0.8% (3 OUT OF 389) IN THE PAXLOVID GROUP COMPARED WITH 7% (27 OUT OF 385) IN THE PLACEBO GROUP

• THE TWO ACTIVE SUBSTANCES OF PAXLOVID COME AS SEPARATE TABLETS THAT ARE PACKAGED TOGETHER AND TAKEN TOGETHER, TWICE A DAY BY MOUTH FOR 5 DAYS

• MHRA IS PROACTIVELY WORKING WITH COMPANY TO ESTABLISH EFFECTIVENESS OF PAXLOVID AGAINST OMICRON

• PAXLOVID AUTHORISED FOR USE IN PEOPLE AGED 18 & ABOVE WHO HAVE MILD TO MODERATE COVID-19 INFECTION & AT LEAST 1 RISK FACTOR FOR DEVELOPING SEVERE ILLNESS

• BASED ON CLINICAL TRIAL DATA, PAXLOVID IS MOST EFFECTIVE WHEN TAKEN DURING THE EARLY STAGES OF INFECTION

• BEFORE PAXLOVID IS PRESCRIBED, MHRA IS ADVISING THAT PATIENTS' CURRENT MEDICATIONS SHOULD BE CAREFULLY REVIEWED

• RISK FACTORS INCLUDE OBESITY, OLDER AGE (>60 YEARS), DIABETES MELLITUS, OR HEART DISEASE

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