Vivek Ra­maswamy’s En­zy­vant is hit with a CRL for man­u­fac­tur­ing — de­lay­ing a new ther­a­py for an ul­tra-rare killer

It was sup­posed to be Vivek Ra­maswamy’s first drug ap­proval, but the re­gen­er­a­tive med com­pa­ny he set up to ad­vance a new tis­sue-based ap­proach to treat­ing an ul­tra-rare con­di­tion in new­borns has been hit with a com­plete re­sponse let­ter from the FDA.

The FDA re­ject­ed En­zy­vant’s RVT-802, which set out to be­come the on­ly ther­a­py sanc­tioned to treat cas­es of pe­di­atric con­gen­i­tal athymia — a con­di­tion marked by ex­treme im­mune de­fi­cien­cy.

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