TG Therapeutics voluntarily withdraws its UKONIQ approval for applications in marginal zone lymphoma (MZL) and follicular lymphoma (FL) that it had received from US FDA in February 2021. This is based on recent data for Unity Phase 3 trials. Although, the product never accounted for large part of Alembic’s revenues as it was in build up phase, its a little sad as this was the first NDA approval for a drug developed by Indian scientists. The detailed press release is below.
Disclosure: Invested (position size here, bought few shares in last 30 days)
Updates: As I read through the press release, it seems that the initial Phase 3 study had passed the primary endpoint. However, there was a secondary endpoint which wasn’t met initially, company claims that this was because the trials were not designed to collect that data properly. FDA wanted to be sure that the secondary end point was also met and they called a committee to judge the scientific appropriatness of the same while judging a subsequent BLA/sNDA application by TG Therapeutics. For this new application, there was another trial which was organized where the secondary data point was properly collected. As results of the secondary data point was analyzed, company realized that the therapy doesn’t do what its supposed to do. Thus, they withdrew their new application and along with retracting their older approval.
Note: I might have oversimplified this explanation, this is what the press release kind of says. Although, I am not a biology/drug expert, so please read the press release for yourself at the link above.