Inundated by demand, Gilead halts individual emergency access to experimental Covid-19 drug

Slammed with a tidal wave of compassionate use requests, Gilead says it will have to put a halt to meeting individual appeals for their coronavirus drug remdesivir while they focus on wrapping a clinical trial to see if it works.

In recent days, the anti-malarial drug chloroquine and similar drug hydroxychloroquine have soaked up the spotlight as potential “game-changers” to combat the coronavirus scourge that has enveloped the globe. But Gilead’s antiviral remdesivir was one of the first to be touted as a potential therapy and is also one of the furthest along the path towards approval.

Now, as the emergency use access requests pile up, the company says it will switch focus to securing expanded access to the investigational drug — weeks ahead of keenly anticipated clinical trial data. Their statement notes:

In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to remdesivir, related to the spread of the coronavirus in Europe and the United States. This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic…

During this transition period, we are unable to accept new individual compassionate use requests due to an overwhelming demand over the last several days. We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.

The drug, which failed to pass muster as an Ebola treatment, is a broad-spectrum antiviral, and is engineered to hit the core machinery virus’ use to reproduce, called polymerase. Next month, Gilead is expected to produce the first batch of data to show if it works in Covid-19 patients or not. The drug is being evaluated in multiple trials.

For many severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective, Gilead has provided emergency access to the investigational drug for several hundred patients in the United States, Europe and Japan.

But as confirmed global cases top 340,000 and the virus rages across the United States and Europe, demand for remdesivir has exploded and overwhelmed the emergency treatment access system, Gilead said on Sunday.

Therefore, the company is transitioning from individual compassionate use requests to expanded access programs, in line with geographical regulations. During this transition period, Gilead will not be able to accommodate new individual compassionate use requests, it said, apart from those for pregnant women and children less than 18 years of age with confirmed Covid-19 infections with “severe manifestations” of the disease.

Remdesivir is currently in a crop of clinical trials.

Source: Evercore ISI analyst Umer Raffat, 2020

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When the results are reported, Evercore ISI’s Umer Raffat expects the drug to perform very well in a certain subset of patients. “This subset will be patients who initiated remdesivir relatively closer to when they got infected,” he wrote in a note earlier this month.

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