La EMA autoriza la primera pastilla contra la covid, el Paxlovid de Pfizer
Repost original desde DW
La pastilla servirá para “adultos que no requieren oxígeno suplementario y que tienen un mayor riesgo de que la enfermedad se vuelva grave”, dijo la EMA este jueves (27.01.2022) en un comunicado.
Paxlovid contiene dos principios activos, PF-07321332 y ritonavir, que se administran en dos comprimidos diferentes que deben tomarse una vez cada 24 horas durante cinco días.
El primer activo reduce la capacidad del virus para multiplicarse en el cuerpo, mientras que el segundo prolonga la acción de PF-07321332, es decir, le permite permanecer más tiempo en el cuerpo.
Para llegar a su conclusión, la EMA realizó un estudio con dos grupos, uno que recibió Paxlovid y otro al que le fue administrado un placebo.
Producción de Paxlovid en laboratorios de Pfizer, en Friburgo, Alemania.
Durante el mes siguiente, el 0,8 % (8 de 1039) de los pacientes que recibieron Paxlovid estuvieron hospitalizados durante más de 24 horas, en comparación con el 6,3 % (66 de 1046) de los que ingirieron el placebo. No hubo muertes en el grupo del antiviral de Pfizer, mientras que en el segundo se produjeron nueve defunciones.
"Paxlovid es el primer antiviral oral para uso doméstico en nuestra cartera y tiene el potencial de marcar una diferencia real para las personas con alto riesgo de progresión a covid grave", declaró en un comunicado la comisaria europea de Sanidad, Stella Kyriakides, tras aprobar el fármaco.
La EMA había ya otorgado licencia al Paxlovid para casos de emergencia, bajo decisión individual de las autoridades nacionales.
Tratamiento de un paciente con COVID-19 en un hospital de Alemania.
España ha adquirido de manera bilateral 344.000 dosis de Paxlovid, que se sumarán a las que le corresponda por la compra centralizada que realice la UE.
El fármaco de Pfizer es el sexto contra el Sars-CoV-2 autorizado en la Unión Europea (anakinra, regdanvimab, tocilizumab, casirivimab/imdevimab, remdesivir y sotrovimab), cuyos servicios analizan en fase inicial otros medicamentos contra la enfermedad de la pandemia (ixagevimab/cilgavimab) y otros dos de cara a una pronta autorización (molnupiravir y baricitinib).
"Estamos haciendo un buen progreso en nuestra segunda línea de defensa: terapias prometedoras que pueden hacer una contribución real para mitigar el impacto de la covid", añadió la comisaria de Sanidad en un comunicado.
Kyriakides agregó que la Comisión sigue trabajando con los Estados miembros en reforzar la respuesta terapéutica contra el coronavirus, incluida la identificación de nuevas vacunas tras la aprobación de seis profilácticos en la UE (Biontech-Pfizer, Moderna, Astrazeneca, Johnson & Johnson y Novavax), y otras cuatro en fases iniciales de análisis (Sputnik V, Sinovac, Sanofi y Valneva).
CP (efe, afp) La EMA recomienda Paxlovid, el primer antiviral oral contra el covid en la UE | Europa | DW | 27.01.2022
Repost original desde la EMA
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 / ritonavir) for the treatment of COVID-19. The applicant is Pfizer Europe MA EEIG.
The Committee recommended authorising Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating COVID-19. It contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of PF-07321332 enabling it to remain longer in the body at levels that affect the multiplication of the virus.
In reaching its conclusion, the CHMP evaluated data from a study involving patients with COVID-19 showing that treatment with Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19. The analysis was done in patients who received Paxlovid or placebo (dummy treatment) within 5 days after COVID-19 symptoms began and who did not receive, nor were expected to receive, treatment with antibodies. Over the month following treatment, 0.8% (8 out of 1,039) of the patients receiving Paxlovid were hospitalised for longer than 24 hours, compared with 6.3% (66 out of 1,046) of those who received placebo. There were no deaths in the Paxlovid group and 9 deaths in the placebo group.
The majority of patients in the study were infected with the Delta variant. Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants.
The safety profile of Paxlovid was favourable and side effects were generally mild. However, ritonavir is known to affect the action of many other medicines, and warnings and advice have been included in Paxlovid’s product information. In addition, the company has provided a drug interaction tool on its website which can be accessed through a QR code included in the product information and on the outer carton. A letter will be sent to relevant healthcare professionals’ organisations to further remind them of the issue. The CHMP concluded that the medicine’s benefits are greater than its risks for the approved use and will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States.
The product information for Paxlovid contains information for healthcare professionals, a package leaflet for members of the public and details of conditions of the medicine’s authorisation.
An assessment report with details of EMA’s evaluation of Paxlovid and the full risk management plan will be published shortly. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course.
More information will also be made available in an overview of the medicine in lay language, including a description of the medicine’s benefits and risks and why EMA recommended its authorisation in the EU.
The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Paxlovid, allowing this medicine to be marketed across the EU.
Conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of medicines during public health emergencies in the EU. CMAs allow authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.
A CMA guarantees that the approved medicine meets rigorous EU standards for efficacy, safety and quality and is manufactured in approved, certified facilities in line with high pharmaceutical standards for large-scale production.
Once a CMA has been granted, companies must provide further data within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.
For Paxlovid the company that markets the medicine will provide further data to reinforce the assurance on the pharmaceutical quality of the medicine.
Assessment of Paxlovid
During the assessment of Paxlovid, CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of Paxlovid, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
Paxlovid was evaluated as part of ‘OPEN’, an initiative started in December 2020 with the aim of increasing international collaboration in the EU review of COVID-19 vaccines and therapeutics. More information can be found on the EMA’s governance during COVID-19 pandemic webpage.
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