24th Aug 2023 16:24
(Alliance News) - AstraZeneca PLC and Merck & Co Inc on Thursday jointly said its Lynparza treatments have been approved in Japan.
Merck & Co is a New Jersey, US-headquartered pharmaceutical maker. AstraZeneca is a Cambridge-based pharmaceutical company.
Merck & Co and AstraZeneca said Lynparza has been approved for the treatment, in combination with abiraterone and prednisolone, for the treatment of adults with BRCA-mutated castration-resistant prostate cancer.
Lynparza is a PARP inhibitor and a targeted treatment to block DNA damage response, and is used to treat forms of cancer.
Lynparza, the firms said, received approval based on phase 3 trial results showing the drug combination reduced the risk of disease progression or death by 77% compared with just abiraterone alone.
They added Lynparza is the first PARP inhibitor approved in Japan to "demonstrate clinically meaningful benefits in combination with a new hormonal agent".
Dave Fredrickson, executive vice president of oncology at AstraZeneca said: "This Lynparza combination has been shown to reduce the risk of disease progression or death compared to standard of care and underscores the critical importance of BRCA testing at metastatic diagnosis.
"Today's approval is a major step forward for patients in Japan with BRCA-mutated metastatic castration-resistant prostate cancer who urgently need new first-line treatment options."
Separately, AstraZeneca said Soliris received approval for the treatment of paediatric patients with generalised myasthenia gravis.
Soliris inhibits the C5 protein in the body's immune system, preventing the body from attacking its own cells, and is used to treat myasthenia gravis, a muscle weakening condition.
AstraZeneca said Soliris is the first treatment approved for children with gMG in Japan. In a phase 3 trial, the drug proved to reduce the severity of the disease, and showed sustained improvements in patients over the 26 week trial period.
Keiko Ishigaki, from the Tokyo Women's Medical University said: "Today’s expanded approval of Soliris in Japan demonstrates the impact of C5 complement inhibition in treating gMG, offering paediatric patients a targeted option with the potential to preserve muscle function and reduce disease severity."
AstraZeneca shares were down 0.2% to 10,752.00 pence each on Thursday afternoon in London. Merck & Co Inc shares were down 0.8% to USD11.43 in New York.
By Sophie Rose, Alliance News reporter
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