Back in January, Takeda won approval for a new indication for its primary immunodeficiency drug HyQvia, this time as a treatment for a rare autoimmune disorder called chronic inflammatory demyelinating polyneuropathy.
Now, the FDA is questioning part of the clinical package that helped win the approval via a warning letter published Tuesday. The letter, which was sent in May to one of the doctors who worked on the Phase 3 trial, highlights several deficiencies found in a 2023 inspection dealing with the way he conducted his portion of the trial.
The FDA took issue with Konrad Rejdak, the Poland-based doctor, and his comments that part of the problem with the trial was poor internet connection during the pandemic. As a result, some of the assessment data for the placebo-controlled trial were entered into tablets “at a later time, either based on written notes or on their memory.”
The warning letter notes
