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On October 26, the FDA held an advisory committee meeting on Daprodustat, GSK's oral chronic kidney disease anemia (CKD) drug, and the mixed vote was mixed, half for and half against
.
The FDA's Advisory Committee on Cardiovascular and Renal Drugs (CRDAC) gave two votes
.
For dialysis-dependent (DD) patients, the vote was 13 votes in favor and 3 votes no, experts believe that the efficacy of treatment with daplastat is considerable, and the convenience of medication can greatly reduce the burden on patients; In addition, there was no increased
cardiovascular risk of dapsastat compared with erythropoietin (ESA).
For patients with non-dialysis dependence (NDD), the vote was 11 no and 5 votes in favor, and experts believe that the risk of daplastat treatment is too high, not only heart failure and stomach erosion bleeding (also in the dialysis patient group), but also heart attack, stroke, and other potential complications, and the benefits of treatment cannot offset the risk
.
GSK was pleased
to receive the voting results.
Daprostat is a novel oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), first approved for marketing in Japan in June 2020 for the treatment of anemia
in adults with chronic kidney disease.
The world's first HIF-PHI drug is AstraZeneca/FibroGen's roxadust, which has been approved in China, Japan, the European Union and other countries and regions for the treatment of chronic renal anemia
in adults with NDD and DD.
However, in August 2021, the FDA refused to approve the marketing
of roxadustat due to safety concerns (increased risk of blood clots, serious infection, death, etc.
).
At the end of March 2022, the marketing application of another HIF-PHI drug, vadadustat, was also rejected by the FDA, again due to safety issues, benefit-risk assessment can not support its marketing
.
So far, no HIF-PHI drugs have been approved in the United States for the treatment of anemia
in chronic kidney disease.
When the vote is half for and half against, it's hard to predict which side
the FDA will favor.
Daprosta PDUFA is dated Feb.
1, 2023, and if the vote ultimately plays a role in the FDA's decision, daplastat could at least make up for the setback
suffered by the previous two oral HIF-PHI classes.
At present, there are 6 HIF-PHI drugs for anemia in chronic kidney disease in the world, and only
roxadustat is listed in China.
According to AstraZeneca's financial report, the sales of roxadustat reached 180 million US dollars in 2021, mainly from the Chinese market
.
In addition to roxastat, the fastest progress in China include Salubris' onastat (declared for marketing) and Kangzhe Pharmaceutical's deduchistal (phase III clinical trial).
