COVID-19 oral antiviral, Paxlovid, approved by UK regulator

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A COVID-19 treatment called Paxlovid (PF-07321332 and ritonavir) was approved by the Medicines and Health Products Regulatory Agency (MHRA) after it was found to be safe and effective in reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at increased risk of developing serious illness.

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.

Developed by Pfizer, Paxlovid is an antiviral medicine containing a combination of active ingredients, PF-07321332 and ritonavir, which works by inhibiting a protease necessary for the virus to replicate. This prevents it from multiplying, keeping virus levels low, and helping the body overcome viral infection. Ritonavir slows down the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.

The two active substances in Paxlovid are presented as separate tablets which are packaged together and taken together, twice a day orally for 5 days. PF-07321332 is a new antiviral, which means it has not yet been approved for use. However, ritonavir has been used with some anti-HIV drugs for many years to “increase” their potency, which is similar to what it does for PF-07321332.

In a clinical trial in high-risk adults with symptomatic COVID-19 infection, five-day treatment with Paxlovid reduced the risk of COVID-19 hospitalization and death by 89% within 28 days compared to to a placebo group at the start of treatment. within 3 days of the onset of symptoms of COVID-19. The number of hospitalizations and deaths was 0.8% (3 of 389) in the Paxlovid group versus 7% (27 of 385) in the placebo group. Similar favorable results were seen in patients when treatment was started within 5 days of onset of symptoms.

Based on clinical trial data, Paxlovid is most effective when taken during the early stages of infection and therefore the MHRA recommends its use as soon as possible and within five days of onset of symptoms. It has been cleared for use in people 18 years of age and older who have mild to moderate COVID-19 infection and at least one risk factor for developing serious illness. These risk factors include obesity, old age (> 60 years), diabetes mellitus or heart disease.

It is too early to know if the omicron variant has an impact on the effectiveness of Paxlovid, but the MHRA is proactively working with the company to establish this.

Dr June Raine, Executive Director of the MHRA, said:

“Today, we gave our regulatory approval for Paxlovid, a COVID-19 treatment that has reduced hospitalizations and deaths from COVID-19 by 89% when taken within three days of onset. symptoms.

“We now have another antiviral drug for the treatment of COVID-19 that can be taken orally rather than given intravenously. This means it can be administered outside of a hospital, before COVID-19 reaches a severe stage.

“I hope today’s announcement reassures those particularly vulnerable to COVID-19, for whom this treatment has been approved. For these people, this treatment could save their lives.

Professor Sir Munir Pirmohamed, Chairman of the Commission on Human Medicines, said:

“The Commission for Medicinal Products for Human Use and its COVID-19 Therapeutics Expert Working Group independently reviewed the data and approved the regulatory approval of Paxlovid by the MHRA.

“Based on this data, it is clear that Paxlovid is another safe and effective treatment to help us in our fight against COVID-19. As it is deployed, we will monitor its effectiveness and safety in the real world, including any drug interactions, as we do with all drugs. Any side effects should be reported to the MHRA using the yellow card system.

Health and Social Affairs Secretary Sajid Javid said:

“The UK has been a world leader in the research and deployment of COVID-19 treatments for patients. This is further proven by the fact that the MHRA is one of the first in the world to endorse this life-saving antiviral.

“We are also leading the whole of Europe in the number of antivirals we have purchased per person – with over 2.75 million courses of this antiviral secured for NHS patients by the Antivirals Taskforce .

“The recall campaign, testing and antiviral defenses ensure our country is in the strongest possible position to face the threat posed by Omicron as the New Year dawns.”

Paxlovid may interact with certain other medicines. Before it is prescribed, the MHRA therefore advises that patients’ current medications should be carefully reviewed, and appropriate advice given on any adjustments that may be required to their current medications. Additional testing may also be required for its safe use. Further information is provided in the Patient Information Leaflet.

Paxlovid does not replace vaccination against COVID-19. Vaccination and a booster after the first course remains the best way to avoid hospitalization from COVID-19 for most people. The government and the NHS will confirm how this COVID-19 treatment will be delivered to patients in due course.

Notes to Editors The Medicines and Health Products Regulatory Agency is charged with protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK, ensuring that they work and are sufficiently safe. All of our work is backed by solid, fact-based judgments to ensure the benefits justify the risks. The MHRA is a center of the Medicines and Health Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Ministry of Health and Social Affairs. The Commission for Medicines for Human Use (CHM) advises ministers on the safety, efficacy and quality of medicines. The CHM is a non-ministerial public advisory body sponsored by the Ministry of Health and Social Affairs. MHRA’s conditional marketing authorization for Paxlovid is only valid in Great Britain. Emergency use authorization has been granted to Northern Ireland to ensure access throughout the UK. Both authorizations were made on the basis of the same rigorous assessment. More information can be found in the product information

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