Which manufacturer produces Niraparib?

Niraparib (Niraparib), the original drug, was originally developed and produced by GlaxoSmithKline (GSK). It is an oral, once-daily PARP inhibitor used for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer. It was approved for medical use in the United States and the European Union in 2017. The U.S. Food and Drug Administration (FDA) will limit the second-line maintenance indication of niraparib to patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut).

The first-line U.S. indication for niraparib remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The primary endpoint of the NOVA trial study was progression-free survival (PFS), assessed in two independent powered cohorts (gBRCAmut and non-gBRCAmut); results showed that niraparib had clinically meaningful and statistically significant benefits in both cohorts and in the HRD subgroup in the non-gBRCAmut cohort. Secondary endpoints were safety and long-term exploratory endpoints, including overall survival, with a hazard ratio of 1.06.

NiraparibThe original drug has been launched in China and is included in medical insurance, but reimbursement is limited to eligible patients. The price of a common specification100mg*30 capsules per box may be more than 5,000 yuan. The original niraparib drug marketed overseas is more expensive than domestically. There are also generic niraparib drugs produced in other countries. Their pharmaceutical ingredients are basically the same as those of the original niraparib drug sold domestically and abroad. The price of 100mg*30 tablets per box produced by a Bangladesh pharmaceutical factory may be more than 1,000 yuan (the price may fluctuate due to exchange rates).