Regulatory Roundup: FDA Investigates adzynma,Otsuka’s Voyxact Approved,and Daiichi Sankyo Wins Patent Battle

The FDA is investigating a safety signal from Takeda‘s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi sankyo won reversal of an unfavorable ruling in its patent fight against Pfizer’s Seagen. Hear’s a closer look.

FDA Launches Investigation into Takeda’s Adzynma Following Reported Pediatric Death

The FDA is investigating Takeda’s Adzynma after a reported death in a child. This drug, approved for the rare blood disorder congenital thrombotic thrombocytopenic purpura, is facing scrutiny.Postmarketing reports indicate patients have developed neutralizing antibodies against the drug’s ADAMTS13 protein ingredient. takeda maintains they’ve found no confirmed causal link between Adzynma and the reported death.

In Crowded Kidney Disease Space, Otsuka receives FDA Approval for First-in-Class Voyxact

otsuka secured accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). This is a significant win. Voyxact is the first biologic cleared for this kidney disease and uniquely blocks the APRIL protein. In a phase 3 trial, Voyxact demonstrated a placebo-adjusted 51% reduction in proteinuria at nine months before entering a competitive market. It’s a monthly, self-administered drug, offering a new option for patients.

Daiichi Sankyo Prevails on Appeal in long-Running ADC Patent Battle with Seagen, Flipping Prior $41.8M Verdict

Daiichi Sankyo achieved a victory in its protracted antibody-drug conjugate patent dispute with Pfizer’s Seagen. The U.S. Court of Appeals overturned a previous ruling that found Daiichi infringed a Seagen patent with Enhertu. This reversal flips a prior $41.8 million verdict in Seagen’s favor, marking a major turning point in the case.