Dr. Reddy’s Laboratories Canada Inc., on behalf of a consortium, has filed an application with Health Canada seeking authorisation for Reeqonus (favipiravir) tablets for the acute treatment of mild to moderate COVID-19 adult patients. “Dr. Reddy’s is working closely with Health Canada for an expedited review of the drug application as speed to market is essential”, VP and general manager Vinod Ramachandran said. “If approved, it will launch the product soon for COVID-19 patients in Canada,” he added.
Dr. Reddy’s Canada has filed the application on behalf of the consortium comprising Dr. Reddy’s Laboratories, Appili Therapeutics and Global Response Aid FZCO (GRA) under Health Canada’s interim order “respecting the importation, sale and advertising of drugs for use in relation to COVID-19.”
“We are pleased to work with our partners at GRA and Appili to be the first in Canada to file an application for oral solid tablets for COVID-19 treatment under Health Canada’s Interim Order,” Mr. Ramachandran said.
In September, Canada Minister of Health had signed the interim order towards creating a new authorisation pathway that will help expedite authorisation of drugs and vaccines for COVID-19. According to Health Canada, Reeqonus (favipiravir) tablets are the first oral solid dosage form submitted under the interim order, the release said.
Appili Therapeutics CEO Armand Balboni said, “Our role remains to design rigorous trials to obtain the data that identify COVID-19 patients that may benefit from Reeqonus. We look forward to working with our partners in providing information to Health Canada.”
“The filing is a testimony to our commitment of bringing a potential solution to COVID-19 for the Canadian population,” said Mitch Wilson, CEO of GRA.
Reeqonus is also known as Avigan (favipiravir), which is a trademark of Fujifilm Toyama Chemical Co. In India, Dr. Reddy’s had launched Avigan in August following a licensing agreement with Fujifilm, and Dubai-based Global Response Aid (GRA) for development, manufacture and sale of Avigan in all countries except Japan, China and Russia. It had then expected to begin manufacturing Avigan in India, once Fujifilm transfers the technology and regulatory approvals for APIs and formulations are in place, in about three months.
