Viraleze was developed for application in the nasal cavity to help reduce exposure to respiratory viruses, including SARS-CoV-2. The product is registered for sale in Europe and India, and available online in certain markets
This is the first of its kind vaccine for Covid 19 to get the go-ahead
In some countries such as France, Italy, Spain and the Balkan region, Menarini Group will lead the commercialisation effort, as part of an exclusive licensing agreement signed with Glenmark
The drug meets all primary endpoints across 608 patients in Europe and India, strengthening the company's biosimilars pipeline
This marks a meaningful step in the company's continued expansion in the region
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
Inspection included drug device combinations covering our recent filing in nasal sprays domain
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
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