Because of the risk of severe neurologic complications, the Food and Drug Administration has placed a hold on another daily dosage of the Covid Antiviral, previously known as Cimzia, following a patient death. However, this second holds are not new for the drug, and comes with the promise of slightly upgraded versions that offer more protection.
It all started on March 16, when the FDA placed a hold on daily doses of Cimzia after a patient died. But before it gets the label expansion to six doses a day, the agency is waiting for more information on the consistency of the drug, specifically in handling and distribution. A total of 36 individual cases of the rare brain infection went unaccounted for after the initial events, so the FDA is waiting to see if the supply levels of the drug will fluctuate after the extra dosage. Though, per Reuters, the FDA did estimate that there is about a one-in-six chance that the FDA will approve the increased dosage.
And despite the public safety warnings, there are also some positive signs that the ongoing trials of the six-dose version are on track. This new formulation offers “increased protection against infection,” and should help to reduce seizure side effects. According to eHealth, this will also “help patients with longstanding brain infections, such as mycobacterium avium complex (MAC) or Tbacyclinoma multiforme (TMB),” which are rare and could mean “greater attention from FDA.”
Read the full story at Reuters.
Precautions for buying generic Cimzia ahead of FDA approval are still in effect