FDA & EMA COVID-19 Treatment Approvals up to 2022

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Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of authorised treatments and how both regulators got to this point.

 

Citing “unprecedented human, social and economic costs” inflicted by the COVID-19 pandemic, less than a year ago, in May 2021, the European Union (EU) made public its strategy to accelerate the availability of treatments for the disease, reasoning that “vaccines will not eliminate the disease overnight and therapeutics will still be needed.”

At the time the strategy was released, only Gilead’s remdesivir had been approved to treat COVID-19 by the European Medicines Agency (EMA). Their new goal: approve five new therapies before the end of 2021.

The document described efforts to mobilise “all available tools and resources to ensure a genuine gear-change” to accomplish what it classified as an “ambitious but realistic objective.” Making an important concession, the EU admitted that it would grant conditional marketing authorisations, as it did for remdesivir, based on a “less comprehensive dataset than would normally be the case” when the benefits outweighed the risks. In other words, it was determined to take chances.

Nine months after the EU went public with the new strategy, six more treatments have joined remdesivir on the “authorised” list, three have been “endorsed” and two remain under evaluation. Pfizer, Gilead, Roche, Sobi, Celltrion, GSK and Regeneron are the companies with authorised treatments.

Across the Atlantic, the US FDA worked around the clock with developers to “expedite the development and availability of therapeutic drugs and biological products.” Aligned with their European counterparts, the United States had only approved remdesivir at the time of the EU strategy announcement in May 2021.

The main difference? Gilead’s remdesivir remains the only “approved” product in the United States. But it is more a question of semantics since the US has given emergency use authorisation to 13 treatments.

In the same way as the EU introduced a fast-track process, the US created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). “The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness,” reads the FDA website.

 

How COVID-19 treatments can be authorised by the FDA and EMA

Since the FDA and EMA apply different classifications, each with their own advantages and processes, it is no surprise that Europe has given the highest approval designation currently available to six more COVID-19 treatments than the United States.

On one hand, the FDA offers four main designations: Approved, Investigational Treatment (clinical trials), expanded access (also known as compassionate use), Emergency Use Authorisation (effective until the emergency declaration ends), and Off-Label Use (unapproved uses of approved drugs).

“When the FDA approves a drug, it means the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labelling,” explains their website.

On the other hand, the EMA offers two main designations that allow COVID-19 treatments to reach patients: Authorised, and Use Endorsed after Article 5(3) review (intended to support national decision-making before a formal authorisation is issued) – Pfizer’s Paxlovid and MSD’s Lagevrio are two of the eight treatments whose use has been endorsed this way.

“EMA is fully mobilised to support the development and marketing authorisation of safe, effective and high-quality therapeutics and vaccines against COVID-19. The Agency has put in place rapid review procedures related to COVID-19 to deliver assessments of high-quality applications from sponsors in the shortest possible timeframes while ensuring robust scientific opinions,” says an EMA document.

 

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