On December 20, 2023, the United States (US) Food and Drug Administration (FDA) granted Calliditas full approval of TARPEYO® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
STRENGTHENING TARPEYO’S IP
The United States Patent and Trademark Office (USPTO) provided Notice of Allowance for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.”.
PARTNERSHIPS’ MILESTONES ACHIEVED
Commercial partner, Everest Medicines, received approval from China’s National Medical Products Administration (NMPA) of Nefecon® for the treatment of primary IgAN iIn adults at risk of disease progression.
Everest Medicines received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China.
Commercial partner, STADA Arzneimittel AG, submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization (CMA) for Kinpeygo® to standard, or “full”, marketing authorization.
The MHRA of the United Kingdom granted CMA for Kinpeygo for the treatment of IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
STADA request to the EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgAN.
ADVANCING SCIENCE AND OTHER NEWS
The Lancet published the full data from the Phase 3 NefIgArd study.
The FDA accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO and granted Priority Review.
Positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd were announced.
PROMISE OF NOX INHIBITORS RECOGNIZED
EMA Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome
US FDA granted orphan drug designation (ODD) to setanaxib for the treatment of Alport syndrome
Interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with setanaxib was announced. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.
Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.