Patients in need of remdesivir can get special FDA permits

The Food and Drug Administration (FDA) said on Wednesday, July 1, that coronavirus patients who are determined to have a need for the investigational drug remdesivir can get special "compassionate permits" from the agency.

"Kung talagang kailangang-kailangan, puwede natin silang bigyan ng compassionate permit para po sa remdesivir," FDA Director General Eric Domingo said during the Department of Health (DOH)'s daily briefing on Wednesday.

(If they really need it, we can give them compassionate permits for remdesivir.)

Currently, the Philippines only administers remdesivir to hospitalized patients with severe cases of coronavirus

"Binibigay po siya sa mga pasyenteng naospital, 'yung talagang grabeng-grabe ang kanilang COVID at ito mukhang positive po ito dahil nakikita nating umiikli 'yung time ng pagkakaroon nila ng sakit, mula 15 days papunta sa 11 days," Domingo said.

(We give it to patients admitted to hospitals, those who have very severe cases of coronavirus, and it's showing positive signs because we can see that the period of them being sick has been cut down from 15 days to 11 days.) 

Domingo said remdesivir is yet to get a Certificate of Product Registration and remains to be an "investigational" drug in the Philippines.

"Itong last week lamang po in-approve din naman natin dito sa DOH at FDA na 'yung mga pasyente na kahit hindi sila kasama sa clinical trial, kung talagang kailangang-kailangan, puwede natin silang bigyan ng compassionate permit para dito sa remdesivir," said Domingo.

(And just last week, the DOH and FDA approved that for patients who are not part of the clinical trial, if they really need it, we can give them compassionate permits for remdesivir.) 

Domingo said the FDA has so far given "compassionate permits" to 19 patients for remdesivir.

Remdesivir is an antiviral drug originally meant to treat Ebola, but has shown to have treating effects on the coronavirus. Countries like Japan and South Korea have approved it as coronavirus treatment.

The United States has bought stockpiles that affected global supply, but Domingo said there are other suppliers in Asia.

Dexamethasone

Another drug being looked at is dexamethasone, which is an anti-inflammatory drug.

Domingo said dexamethasone is still not part of the Philippines' solidarity trial, a worldwide effort to test already existing drugs and if they have healing effects on coronavirus patients.

"Hinihintay pa natin itong peer review ng study na ito at hindi pa napa-publish 'yung full data on it, pero very promising ito," said Domingo.

(We are still waiting for the peer review of this study and the full data has not been published yet but it is very promising.)

It is being tested in the United Kingdom.

"Sa United Kingdom na gumamit ng 6,000 pasyente, nakita nila na dun sa mga grabeng-grabe ang sakit, itong mga intubated, nababawasan po ang kanilang mortality rate by 30%," said Domingo.

(In the United Kingdom where they used it among 6,000 patients, they saw that for those with severe cases, those already intubated, their mortality rate was cut down by 30%.) 

Domingo said the Philippines is yet to join a clinical trial for a coronavirus vaccine but that the FDA is coordinating with the Department of Science and Technology to join a vaccine trial.

What the Philippines is part of is the solidarity trial for off-label drugs. Off-label means the prescription of a drug for a condition other than that for which it has been officially approved.

Domingo warned not to take these drugs without prescription.

"Kapag kayo po ay walang COVID-19 ay puro side effects lang po ang makukuha niyo rito (If you don't have COVID-19, you will only get side effects)," said Domingo, adding that dexamethasone has not shown an effect on mild cases of coronavirus and most especially on patients with no coronavirus.

"Kapag tinake niyo po ito, puwede kayong magka-high blood, puwede kayong maging diabetic, ang mga buto niyo puwedeng malusaw, para pong rumurupok sila (If you take these you can get high blood, you can be diabetic, your bones will grow weaker)," he added. 

As of Wednesday, the Philippines has 38,511 coronavirus cases, with 1,270 deaths and 10,438 recoveries. – Rappler.com

Lian Buan

Lian Buan covers justice and corruption for Rappler. She is interested in decisions, pleadings, audits, contracts, and other documents that establish a trail. If you have leads, email lian.buan@rappler.com or tweet @lianbuan.

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