The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.
Mitotane for Adrenal Cortical Carcinoma
Mitotane, a steroid hormone synthesis inhibitor and an anti-tumor drug, is used to treat adrenal cortical carcinoma (ACC) and Cushing’s syndrome. Originally developed by Bristol-Myers Squibb, mitotane was first approved in the US in 1970 and initially marketed as an orphan drug for ACC due to limited market demand. HRA took over manufacturing and marketing from BMS in 2019. The drug entered the second list of clinically urgent overseas drugs in mainland China in May 2019, where it is still not yet approved. The priority review indication is for advanced (unresectable, metastatic, or recurrent) ACC.
Ritlecitinib for Alopecia Areata and Ulcerative Colitis
Ritlecitinib, an oral Janus kinase 3 (JAK3) inhibitor, achieves selective inhibition of JAK isozymes through covalent interaction with the JAK3-specific residue CYS-909. The drug, under development for alopecia areata, has entered Phase III clinical trials and received breakthrough therapy designations (BTDs) in the US and China in September 2018 and December 2020, respectively. In June 2022, it received another BTD for the treatment of moderate to severe active ulcerative colitis (UC). The prioritized indication this time is for adolescents and adults aged 12 years and above suitable for systemic treatment of alopecia areata, due to its classification as a breakthrough therapy.
Trientine for Wilson’s Disease
Trientine, a copper ion complexing agent, promotes the elimination of copper from the body through the kidneys. Originally developed by Merck, trientine obtained marketing approval in 1986 for the treatment of Wilson’s Disease in the US, suitable for patients intolerant to penicillamine. Watson Laboratories’ generic version became the first of its kind in February 2018. The drug entered the third list of pediatric research and development and filing encouragement drugs in China in June 2019. Foshan Deruike Pharma made a Category 5.2 filing for its own generic version in March 2020, with priority review status, targeting Wilson’s Disease intolerant to penicillamine. The prioritized indication is for Wilson’s Disease in adults, adolescents, and children ≥ 5 years of age who do not tolerate D-penicillamine treatment, due to its status as a new pediatric drug variety.
Ziresovir for Respiratory Syncytial Virus Infection
Ziresovir, a small molecule inhibitor of respiratory syncytial virus (RSV) fusion protein, combines with the virus’s fusion protein to prevent viral entry into human cells and prevent diseases caused by infection. It also prevents viral fusion between cells, achieving an antiviral effect. A Phase III clinical study for the drug in RSV infection in infants and children completed all patient dosing in January 2022. The prioritized indication is for respiratory infection caused by RSV in children aged two years and under, as a breakthrough therapy.-Fineline Info & Tech
