Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™
July 15, 2021 at 07:34 am EDT
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Ocugen, Inc. announced that it had initiated a rolling submission to Health Canada for COVAXIN™, the company’s candidate vaccine against COVID-19, which it is co-developing with Bharat Biotech International Ltd. for the U.S. and Canadian markets. This follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults. The rolling submission process was recommended and accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission for COVID-19, which permits companies to submit safety and efficacy data and information as they become available. Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. Ocugen initiated the rolling submission through its affiliate, Vaccigen Ltd.Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.
Ocugen, Inc. is a biopharmaceutical company. The Company is focused on discovering, developing, and commercializing gene and cell therapies, biologics, and vaccines that improve health for patients across the globe. The Company's technology pipeline includes modifier gene therapy platform, regenerative medicine cell therapy platform, and biologic therapies for retinal diseases. It is developing COVAXIN, which is a whole-virion inactivated intramuscular COVID-19 vaccine candidate for the North American market. It is also developing a inhaled mucosal vaccine platform, which includes OCU500, a bivalent COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 vaccine. Its modifier gene therapy platform is focused on addressing various retinal diseases, including retinitis pigmentosa (RP), Leber congenital amaurosis (LCA), and Stargardt disease, with a single mutation-agnostic therapy.