Is niraparib on the market?

Niraparib (Niraparib) is an orally active poly(ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells that is selective for PARP-1 and PARP-2. Niraparib was first approved by the U.S. Food and Drug Administration (FDA) in March 2017, approved by the European Commission in November 2017, and approved by Health Canada in June 2019.

Niraparib is approved for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. Approval was based on a randomized trial (NOVA) that included 553 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received at least two prior treatments with platinum-based chemotherapy and who had a complete or partial response to their most recent chemotherapy treatment. The trial showed that patients with BRCA germline mutations who received niraparib had an estimated median PFS of 21 months compared with 5.5 months in the gBRCAmut cohort who received placebo.

In December 2019, niraparibthe original drug has been launched in China and has been included in medical insurance, but it is only reimbursable 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).