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FDA allows emergency use of antibody drug President Trump received

Corona after Time

U.S. health offi­cials Sat­ur­day agreed to allow emer­gency use of a sec­ond anti­body drug to help the immune sys­tem fight COVID-19, an exper­i­men­tal med­i­cine that Pres­i­dent Don­ald was giv­en when he was sick­ened last month.

The Food and Drug Admin­is­tra­tion autho­rized use of the Regen­eron Phar­ma­ceu­ti­cals Inc. drug to try to pre­vent hos­pi­tal­iza­tion and wors­en­ing dis­ease from devel­op­ing in patients with mild-to-mod­er­ate symp­toms.

The drug is giv­en as a one-time treat­ment through an IV. The FDA allowed its use in adults and chil­dren 12 and over who weigh at least 88 pounds (40 kilo­grams) and who are at high risk of severe ill­ness from COVID-19 because of age or cer­tain oth­er med­ical con­di­tions.

Emer­gency autho­riza­tion allows use of the drug to start while stud­ies are con­tin­u­ing to estab­lish safe­ty and effec­tive­ness. Ear­ly results sug­gest the drug may reduce COVID-19-relat­ed hos­pi­tal­iza­tion or emer­gency room vis­its in patients at high risk for dis­ease pro­gres­sion, the FDA said.

Regen­eron said that ini­tial dos­es will be made avail­able to rough­ly 300,000 patients through a fed­er­al gov­ern­ment allo­ca­tion pro­gram. Patients will not be charged for the drug but may have to pay part of the cost of giv­ing the IV.

Ini­tial sup­plies will like­ly be vast­ly out­stripped by demand as the U.S. has surged past 10 mil­lion report­ed cas­es, with the coun­try fac­ing what health experts say will be a dark win­ter due uncon­trolled spread of the virus.

Anti­bod­ies are pro­teins the body makes to tar­get and help elim­i­nate virus­es, but it can take weeks for the best ones to form after an infec­tion occurs. The drugs are con­cen­trat­ed ver­sions of ones that proved best able to do this in lab and ani­mal , and in the­o­ry help the body start to fight the virus right away.

The Regen­eron drug is a com­bo of two anti­bod­ies to enhance the chances it will prove effec­tive. Ear­li­er this month, the FDA gave emer­gency autho­riza­tion to a sin­gle-anti­body drug from Eli Lil­ly that also is still being stud­ied.

There’s no way to know whether the Regen­eron drug helped Trump recov­er; he received a host of treat­ments and most COVID-19 patients recov­er on their own.

FDA reg­u­la­tors autho­rized the Regen­eron drug using their emer­gency pow­ers to quick­ly speed the avail­abil­i­ty of exper­i­men­tal drugs and oth­er med­ical prod­ucts dur­ing pub­lic health crises.

In nor­mal times the FDA requires “sub­stan­tial evi­dence” to show that a drug is safe and effec­tive, usu­al­ly through one or more large, rig­or­ous­ly con­trolled patient stud­ies. But dur­ing pub­lic health emer­gen­cies the agency can low­er those stan­dards and require only that an exper­i­men­tal treatment’s poten­tial ben­e­fits out­weigh its risks.

The emer­gency autho­riza­tion func­tions like a tem­po­rary approval for the dura­tion of the COVID-19 pan­dem­ic. To win full approval, Regen­eron will have to sub­mit addi­tion­al research to ful­ly define the drug’s safe­ty and ben­e­fit for patients.

The White House cast the deci­sion as a vic­to­ry for Trump’s efforts “to deliv­er cut­ting-edge treat­ments with high­ly promis­ing results to pro­tect the health and safe­ty of the most vul­ner­a­ble Amer­i­cans,” accord­ing to a state­ment from spokesman Michael Bars.

___

AP health writer Matthew Per­rone con­tributed to this report.

___

The Asso­ci­at­ed Press Health and Sci­ence Depart­ment receives sup­port from the Howard Hugh­es Med­ical Institute’s Depart­ment of Sci­ence Edu­ca­tion. The AP is sole­ly respon­si­ble for all con­tent.

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