- Gilead will stop granting individual access to its experimental treatment for COVID-19, citing an "exponential increase" in compassionate use requests for the antiviral drug, called remdesivir.
- Instead, the biotech plans to transition to an expanded access program that it says will speed the process for severely ill patients while allowing for better data collection.
- Five clinical studies testing remdesivir in patients infected by the new coronavirus are currently ongoing, and could begin to yield results by next month. The drug's quickly become a top treatment hope, boosted most recently by bullish comments from President Donald Trump in a press conference last week.
Compassionate use, as Gilead noted in its Sunday statement, was not designed to facilitate widespread access to experimental drugs during a public health emergency.
So far, the biotech has provided remdesivir to "several hundred" patients sick with COVID-19 in the U.S., Europe and Japan.
But as the pandemic has intensified, so too has demand for remdesivir, which is viewed as particularly promising by both researchers and U.S. officials.
"In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to remdesivir," Gilead said in its statement.
The lack of an approved treatment for COVID-19 has created intense urgency to speed potential therapies to physicians and patients desperate for options. But providing drugs through compassionate use could have the unintended consequence of slowing data collection via clinical study, the principal vehicle for proving an experimental treatment is safe and effective.
A Phase 2 study of remdesivir being led by the U.S. government, for example, is targeting enrollment of just under 400 patients — not much more than the several hundred patients who've accessed the drug through compassionate use, albeit globally.
While Trump incorrectly implied in a Mar. 19 press conference that remdesivir was "essentially approved," Food and Drug Administration Commissioner Stephen Hahn has emphasized that approval would still rely on data generated in clinical testing.
"We need to actually know about the safety and the effectiveness, and that’s done through the clinical trial process," Hahn said.
The world may not have much longer to wait until data from remdesivir studies starts to become available. Gilead expects there will be results within weeks from two Phase 3 studies being conducted in China, and two of its own trials could conclude shortly thereafter.
"By the time we get to the end of April, we should have a preliminary idea of the safety and efficacy of this medicine against coronavirus," said Gilead CEO Daniel O'Day in a press conference earlier this month.
In the meantime, Gilead will begin an expanded access program to take the place of providing remdesivir through compassionate use. The company said launching such a program would take a similar amount of time as processing any new requests for compassionate use access would have.
Exceptions, however, will be made for pregnant women and children under the age of 18, Gilead said.
Remdesivir isn't the only drug drawing attention. A decades-old malaria drugs — hydroxychloroquine — are now in the spotlight after a small study in France suggested the treatments might have activity against the new coronavirus, though the findings have yet to be validated through larger, randomized trials. In response to that and comments by U.S. officials, drugmakers have begun to ramp up production and announce planned donations of tens of millions of tablets.