Takeda Pharmaceutical Company Limited (NYSE: TAK) declared Friday that it has submitted New Drug Application (NDA) for Lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan. Lanadelumab is the monoclonal antibody cure against the attacks of hereditary angioedema (HAE).
In 2018, Lanadelumab has obtained authorization for the prevention of HAE attacks in sufferers between the age of 12 and older. It is now accessible in more than 20 countries with extra governing proposals continuing internationally. The filing of NDA is based on the outcomes of the global Phase 3 HELP trial and the Phase 3 HELP trial Open-label Extension (OLE). Additionally, the temporary outcomes of a Phase 3 trial assessing the usefulness and protection of Lanadelumab in Japanese participants.
Furthermore, these trials have demonstrated that Lanadelumab is the preventive cure against HAE. In the HELP trial, nearly 125 participants suffering from HAE have shown a reduction in the attacks after getting the treatment. Japanese PMDA will assess the regulatory submission in Japan. For the final decision regarding the NDA, the PMDA will send the assessment data to MHLW.
HAE is a rare genetic disease, and it has affected the projected 1 in 50,000 people all around the globe. Reports have disclosed that between 2,000 and 3,000 people are living with HAE in Japan, but only nearly 450 have been detected due to low knowledge about the diseases in the state.