Why did the FDA deny Rigel’s EUA request for his COVID-19 therapy?

Not all COVID-19 vaccines or therapies earn Emergency Use Authorization (EUA). Rigel Pharmaceutical (NASDAQ: RIGL) recently received a favorable opinion from the Food and Drug Administration for an EUA dossier for its therapeutic candidate COVID. In this Motley Fool Live video registered on August 18, 2021Motley Fool contributors Keith Speights and Brian Orelli explain why the FDA denied an EUA for Rigel’s experimental COVID therapy.

Keith Speights: Let’s move on to a non-COVID-19 story. In fact, it’s a COVID-19 story, but it’s not a vaccine story. The FDA has denied authorization for emergency use for Rigel Pharmaceuticals’ investigational therapy COVID-19, even though the company has reported positive results from a Phase 2 study.

Brian, why did the FDA forward this rejection to Rigel?

Brian Orelli: Yes. This was only a phase 2 study, and the study only involved 59 patients. It seems that this was not enough for the FDA, especially at this end of the pandemic. Maybe if they had the data and they were the first drug trying to get emergency use clearance, maybe that would be enough.

When all hospitals are fully converted, but at this point, the FDA seems to want more data on conducting a phase 3 clinical trial. The drug is already approved as a second-line treatment for thrombocytopenia. It bears the brand name Tavalisse, TAVALISSE. The company plans to complete recruitment in this clinical trial by the end of this year. Then the NIH [National Institutes of Health] is also studying the drug in a phase 3 study platform that has just started.

The data for this test will therefore take some time. But I think it’s disappointing for the company because they could have had sales if the FDA had approved based on the phase 2 data. Now they’re going to have to wait until phase 3, and when where they get the phase 3 data and then submit the emergency use authorization.

Now, hopefully, more and more people have been vaccinated, and as a result, the number of people needing treatment will have dropped significantly. Unfortunately, I think they missed a lot of their potential for this drug, at least as a COVID-19 treatment. They still have it as a treatment for thrombocytopenia.

Speights: Well. The company, Rigel CEO Raul Rodriguez, said if the Phase 3 study meets its goals, the company plans to resubmit its EUA dossier with the additional data.

I think there is a bigger story here. I think a lot of people may have been skeptical of the FDA’s EUA process, that they are cutting corners, that the agency is rushing through the process and bringing to the market vaccines and therapies that don’t. have not really been examined closely. I think that’s at least one example that shows that no, it isn’t. The FDA is really looking at the data, and if the data doesn’t support the safety and effectiveness of a vaccine or therapy for COVID-19, it won’t get EUA, and I think it is. is what we see here.

Orelli: Yes. At first I think there was a lot more pressure to get them to give emergency use permissions. But I think now, with fewer people needing it and already having treatments on the market, I think it puts pressure on the laggards to produce more data than the first ones.

This article represents the opinion of the author, who may disagree with the “official” recommendation position of a premium Motley Fool consulting service. We are heterogeneous! Challenging an investment thesis – even one of our own – helps us all to think critically about investing and make decisions that help us become smarter, happier, and richer.


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