Authorisation to market their new antiviral Covid medicine in Europe is expected shortly by Pfizer
The European Medicines Agency (EMA) announced this Monday, January 10, that it is evaluating a request from Pfizer for conditional marketing authorisation for their oral antiviral medicine ‘Paxlovid’.
Their new product has been developed for the treatment of adult and adolescent patients who are displaying mild to moderate Covid-19 symptoms. It is suitable for anybody from 12 years of age, with a minimum weight of 40 kilos, who presents a high risk of progression to a serious condition with the virus.
Pfizer is hoping that the EMA will assess the benefits and risks of ‘Paxlovid’ in a short period of time. Approval could then be given “in a matter of weeks”, depending on “whether the data presented is sufficiently robust, and whether more information is needed to support the assessment”.
This accelerated schedule is possible because the EMA’s Committee for Medicinal Products for Human Use (CHMP) has already initiated a review of data on the medicine during an ongoing review. The review included data from laboratory studies, animals, and clinical, as well as data on the quality of the medicine.
Interim results were also evaluated by the CHMP of the main study on the use of ‘Paxlovid’ in non-hospitalised, unvaccinated patients, affected by Covid-19. These were patients who had symptomatic disease and at least one underlying condition that put them at risk of having a serious illness.
‘Paxlovid’ is an oral antiviral medication that reduces the ability of SARS-CoV-2 to multiply in the body. The active principle PF-07321332 blocks the activity of an enzyme necessary for the virus to multiply.
Paxlovid also provides a low dose of ritonavir, which slows down the breakdown of PF-07321332, allowing it to stay in the body for longer at levels that affect the virus. The forecast is that ‘Paxlovid’ will reduce the need for hospitalisation of patients with coronavirus.
Pedro Sanchez, the President of the Government, already mentioned this Monday, January 10, in an interview on Cadena SER, that Spain will buy 344,000 doses of this antiviral that Pfizer is manufacturing in January, that, as he explained, “reduces the possibility of hospitalisation of vulnerable patients by 88 percent”, as reported by mallorcadiario.com.