Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treat­ment Vek­lury have been re­called by Gilead, the com­pa­ny said last week, af­ter the ap­pear­ance of glass par­tic­u­lates. A cus­tomer com­plaint was con­firmed by Gilead’s in­ves­ti­ga­tion.

Vek­lury, al­so known as remde­sivir 100 mg for in­jec­tion, is used in more than half of hos­pi­tal­ized pa­tients with Covid-19, ac­cord­ing to Gilead. It raked in around $2.8 bil­lion last year, and was the on­ly drug ap­proved by the FDA for this set­ting. But a study out of Eu­rope dubbed Dis­CoV­eRy found that no clin­i­cal ben­e­fit was ob­served in pa­tients who re­ceived the drug over those who got stan­dard of care alone. And while pre­vi­ous stud­ies have linked remde­sivir to a faster time to re­cov­ery, that re­sult was not seen in the Dis­CoV­eRy tri­al.

Those re­sults have peo­ple ques­tion­ing the drug’s ap­proval, and its cost of $3,000. The FDA gave it full ap­proval in Oc­to­ber based on three dif­fer­ent stud­ies.

The drug gained emer­gency use au­tho­riza­tion in May 2020, and was fa­mous­ly giv­en to US Pres­i­dent Don­ald Trump when he was bat­tling the coro­n­avirus. Gilead has said that the drug re­duced the risk of death by 62% when com­pared with oth­er stan­dards of care.

The treat­ment is in­tend­ed for adults and chil­dren above the age of 12 who re­quire hos­pi­tal­iza­tion for Covid-19. The two lots af­fect­ed by the re­call, 2141001-1A and 2141002-1A, were dis­trib­uted through­out the US in Oc­to­ber 2021. They both have ex­pi­ra­tion dates of Jan­u­ary 2024.

If a drug with glass par­tic­u­late is in­ject­ed in­to a pa­tient, side ef­fects could be as sim­ple as red­ness and swelling at the in­jec­tion point, to trav­el­ing to or­gans and block­ing blood ves­sels in the heart, lungs or brain. That can lead to stroke and death.

So far, there have been no re­ports of any events re­lat­ed to the re­call, Gilead said. Any­one who has ex­pe­ri­enced side ef­fects from the shot should reach out to the FDA’s ad­verse event re­port­ing pro­gram on­line at www.fda.gov/med­watch/re­port.htm or by call­ing them at 1-800-332-1088.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

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Illustration: Kim Ryu for Endpoints News

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