Last week (May 22-26), a total of 23 items received item approval from the Ministry of Food and Drug Safety. There were 13 prescription drugs and 10 over the counter drugs.
Approved items are approved for various indications, including type 2 diabetes, major depressive disorder, Parkinson’s syndrome, hyperlipidemia, macular degeneration, and retinopathy.
The antidepressant ‘Nupram Odi Tab.’ There are three types of approved doses: 5mg, 10mg, and 20mg. Jeil Pharm also received permission for ‘Jefram Meltz Orally Disintegrating Tablet’, a production item delivered from Myeongin Pharm, on the 17th.
The Food and Drug Safety Administration has approved Neupramodi for the treatment of major depressive disorder, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.
This drug is a successor to Lundbeck’s ‘Lexapro Tab’, an original drug with the same ingredients approved in December 2004, and is a product that changed the existing film-coated dosage form to an orally disintegrating tablet .
The oxalate component of escitalopram acts as an SSRI (Selective Serotonin Receptor Inhibitor) agent. It prevents the reuptake of serotonin in the body and increases the concentration of serotonin in the central nervous system to treat anxiety disorders and depression.
Currently, a total of 131 items of this ingredient are approved in Korea. Among them, 127 items, excluding Lexapro, are delayed-release drugs, and the items are only Myungin Pharm’s ‘Nupram Odi Tab’ and Jeil Pharm’s ‘Orally Disintegrating Tablet’ first to change their dosage form to oral disintegrating tablets.
With the approval of Neupram Od Tab., Myeongin Pharm has further expanded its line of antidepressants.
In January this year, the company went through a citation decision in the patent invalidation trial, and in April this year, Lundbeck’s ‘Brinterix (ingredient vortioxetine hydrobromide)’ was approved for ‘Bocetin Tab.’ Currently, with Unimed Pharmaceuticals, it has been granted preferential marketing permission, and both companies will be able to sell this product from May 10, 2027.
A total of 20 clinical trial plans were approved. In detail, △8 cases for stage 1 △1 case for stage 2 △4 cases for stage 3 △7 cases for bioequivalent.
These clinical trials have been approved for various diseases such as chronic kidney disease, type 2 diabetes, epilepsy, and atopic dermatitis, and carcinomas such as solid cancer, prostate cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer.
Folate receptor alpha (FRα)-positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer treatment ‘Elahere’ (ingredient: mirbetuxi) which is being developed by ‘Immunogen’, a combination antibody treatment (ADC) company in the United States Son of Soravtan (ADC). IMGN853))’ phase 3 clinical trial plan was approved on the 19th.
ELAHIRE is an ADC treatment that targets FRA, a cell surface protein overexpressed in epithelial cancers such as ovarian cancer.
ADC is made by connecting an antibody that binds to a specific target antigen on the surface of cancer cells and a payload that has a cell death function through a linker. It is distinguished from existing cytotoxic anticancer agents in that it can focus the cytotoxic anticancer agent on cancer lesions, thereby minimizing the damage to normal tissues and maximizing the anticancer effect.
This clinical trial (study name: GLORIOSA) is for patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer with high expression of FRA, who have not progressed after the second-line therapy with platinum-based chemotherapy and bevacizumab (product name: Avastin) A multicenter randomized open-label study of ‘. The research team will compare the effectiveness of bevacizumab + Elaire combination therapy versus bevacizumab monotherapy.
The company set the primary endpoint of this clinical trial as the time from the date of randomization to the time of the investigator’s assessment of disease progression (PD) or death, whichever comes first (PFS). We also report PFS assessed by BICR (Blinded Independent Central Assessment) as a sensitivity study in the same patient population. The primary secondary endpoint was OS (time from randomisation to death).
The target number of patients is 13 (418 worldwide) △Asan Medical Center △National Cancer Center △Seoul National University Bundang Hospital △Termination Hospital △Gangnam Termination Hospital △Seoul St. Hospital. Mary △Hospital Korea University College of Medicine △Hospital △Samsung Keimyung University Dongsan Hospital △There are 11 hospitals, including Cha Bundang Hospital and Guro Hospital affiliated with Korea University Medical School. The projected end date of the trial is October 2029.
Meanwhile, Elaire was conditionally approved by the US FDA on November 16 last year as the first ADC in ovarian cancer.
According to the research data submitted by the company at the time of approval, the study was conducted on ‘patients with platinum-resistant advanced ovarian cancer who had high expression of FRα and who had been treated with systemic therapy including bevacizumab in the past’, and the primary evaluation variable, objective response rate (ORR) was 31.7%, and the duration of drug response (DOR), a secondary endpoint, averaged 6.9 months, which was confirmed to meet all statistical significance.
