FDA Probes Takeda's Adzynma as Otsuka and Daiichi Sankyo Score Wins

The pharmaceutical industry saw significant developments this week, with regulatory actions, drug approvals, and legal battles shaping the landscape. The U.S. Food and Drug Administration (FDA) launched an investigation into Takeda's rare disease medication, while Otsuka celebrated a groundbreaking approval in the kidney disease space. Meanwhile, Daiichi Sankyo emerged victorious in a patent dispute with Pfizer's Seagen.

FDA Investigates Takeda's Adzynma Following Child's Death

The FDA has initiated an investigation into Takeda's Adzynma, a treatment for the rare blood disorder congenital thrombotic thrombocytopenic purpura, following reports of a child's death. The probe centers on postmarketing reports of patients developing neutralizing antibodies against the drug's ADAMTS13 protein ingredient. Takeda stated that no confirmed causal link has been established between the drug and the reported incidents.

Otsuka's Voyxact Receives FDA Approval for IgA Nephropathy

In a significant advancement for kidney disease treatment, Otsuka has received accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). As the first biologic cleared for this condition and the first to block the APRIL protein, Voyxact demonstrated impressive efficacy in clinical trials. The phase 3 trial showed a placebo-adjusted 51% reduction in proteinuria at nine months, positioning Otsuka strongly in the competitive kidney disease market.

Daiichi Sankyo Prevails in ADC Patent Battle with Seagen

Daiichi Sankyo has secured a crucial victory in its ongoing antibody-drug conjugate (ADC) patent dispute with Pfizer's Seagen. The U.S. Court of Appeals reversed a prior ruling that had found Daiichi infringed on a Seagen patent with its drug Enhertu. This decision effectively nullifies a previous Texas court verdict, which had ordered Daiichi to pay royalties to Seagen related to the popular ADC.

ADC Developments and Combinations Show Promise in Oncology

The field of ADCs continues to evolve rapidly, with several companies making strides in development and partnerships. Crescent Biopharma has entered an $80 million upfront deal with Kelun-Biotech for ex-China rights to an integrin beta-6-directed ADC candidate. Crescent plans to explore combination therapies with its PD-1xVEGF bispecific antibody for solid tumors.

In related news, Kelun reported positive phase 3 results for its Merck & Co.-partnered TROP2 ADC, sacituzumab tirumotecan (sac-TMT), in combination with Keytruda. The combo significantly improved progression-free survival compared to Keytruda alone in Chinese patients with first-line PD-L1-positive non-small cell lung cancer.

Furthermore, a combination of Astellas and Pfizer's Padcev with Keytruda received FDA approval as a perioperative treatment for muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy. This regimen, used around surgery, demonstrated a 50% reduction in the risk of death compared to surgery alone in a phase 3 trial.