CHMP recommends Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy.
Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) greater than 1.5 g/gram.
If confirmed by the European Commission (EC), Kinpeygo will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD). Upon approval Kinpeygo, which was developed under the name Nefecon, will be marketed exclusively by STADA Arzneimittel AG in the EU,UK and Switzerland.
The CHMP’s positive opinion will now be forwarded to the EC, which has the authority to grant a marketing authorisation for Kinpeygo in the European Union (EU) member states, and which will be adopted by Iceland, Norway and Liechtenstein. A final decision by the EC on granting a marketing authorisation is anticipated in Q3 2022. Kinpeygo is already marketed under an accelerated approval in the United States under the brand name Tarpeyo.
If confirmed by the European Commission (EC), Kinpeygo will be granted a conditional marketing authorisation that is based on achievement of the primary endpoint of reduction of proteinuria in Part A of the NeflgArd pivotal Phase III study. Patients taking 16mg of Kinpeygo once daily showed a statistically significant 31% reduction in proteinuria from baseline vs 5% in the placebo arm after 9 months of treatment.
Related news and insights
The Menarini Group and Radius Health, Inc. announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announce positive results of the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia (NCT03548584).