Novavax: Partner Takeda Submits NDA In Japan For Approval Of COVID-19 Vaccine

Novavax, Inc. (NVAX), a biotechnology company, announced late Wednesday that its the submission of a New Drug Application or NDA in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Co. Ltd. (TKPHF.PK,TAK).

The NDA was submitted to Japan's Ministry of Health, Labour and Welfare or MHLW.

Novavax stated that its recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant, known as TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 vaccine to be submitted under an NDA in Japan.

With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan. The companies aim to begin distribution in early 2022, pending regulatory approval.

In addition to the submission of the NDA to MHLW in Japan, Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines.

The companies have filed for EUA in India and for Emergency Use Listing with the World Health Organization.

Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, Singapore, United Arab Emirates, and the European Union and with the WHO.

Additionally, Novavax and SK bioscience announced a Biologics License Application submission to MFDS in South Korea. Novavax expects to submit its complete CMC data package to the U.S. FDA by the end of the year.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Elon Musk's brain implant firm Neuralink said it has received approval from the U.S. Food and Drug Administration to conduct first-in-human clinical trials. In a tweet, Neuralink said, "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study! T.W. Garner Food Co. is recalling 50,688 bottles of 12 oz. Texas Pete Buffalo Wing Sauce citing undeclared soy, the U.S. Food and Drug Administration said. The agency noted that some of the bottles may contain Texas Pete Extra Mild Wing Sauce which contains soy. The recall involves Texas Pete Buffalo Wing Sauce with best used by 120623T 065239 UPC 0 75500 10011 6. The U.S. Food and Drug Administration approved Pfizer Inc's COVID-19 oral antiviral pill Paxlovid for the treatment of mild-to-moderate COVID-19 in adults. Paxlovid is the first oral treatment, and the fourth drug, approved by the agency to treat COVID-19 in adults. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved to treat adults who are at high...
Follow RTT