Dr. Reddy’s Canada has filed an application with Health Canada on behalf of the consortium for Reeqonus (favipiravir) tablets for acute treatment of mild to moderate Covid-19 in adult patients.
The submission is under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19.
Dr. Reddy’s Laboratories, Canada-based Appili Therapeutics and Dubai-based Global Response Aid FZCO (GRA) are part of the consortium.
Dr. Reddy’s Laboratories Canada vice-president and general manager Vinod Ramachandran said: “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.
“Dr. Reddy’s is working closely with Health Canada for an expedited review of the drug application, as speed to market is essential in these unprecedented times.”
As per Health Canada, Reeqonus tablets are the first oral solid dosage form submitted under the Interim Order for treating Covid-19.
Appili Therapeutics CEO Dr Armand Balboni said: “Reaching patients early in the infection to prevent possible progression into more serious forms of this disease remains a critical unmet need in the Covid-19 treatment landscape.
“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 with the goal of advancing this important innovation for patients.”
In September, the Minister of Health in Canada signed the Interim Order Respecting the Importation, Sale and Advertising of Drugs for use in Relation to Covid-19 to create a new authorisation pathway that will aid in speeding up the approval of drugs and vaccines for the disease.
In a separate development, the US Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application of Hepion Pharmaceuticals’ new cyclophilin inhibitor, CRV431, for treating Covid-19.