Glenmark’s nasal spray granted marketing approval in India
16 May 2022
Drug Controller General of India (DCGI) has granted Mumbai-based Glenmark Pharmaceuticals marketing approval for its nasal spray for the treatment of adult Covid-19 patients. as part of an accelerated approval process.
The company has formally launched the nitric oxide spray – to be sold as FabiSpray – which is meant to be squirted over nasal mucosa where it will act as a physical and chemical barrier against the virus.
It will “kill the Covid-19 virus in the upper airways”, the company said in its statement, adding that it would soon publish trial data in a peer-reviewed journal.
The product, however, has received a ‘CE’ mark from the European Union – the equivalent of marketing authorisation in case of a medical device and is sold in Bahrain and Israel as ‘envoid’.
Trial data shows “reduction of viral load of 94 per cent in 24 hours and 99 per cent in 48 hours”, the company said, stressing the product was “safe and well-tolerated” by patients.
Nasal sprays and orally-administered drugs are seen as the ‘second generation’ of Covid-19 vaccines that could be made available over the next few weeks and months, Dr Soumya Swaminathan, the World Health Organisation’s chief scientist, said in November.
At present, India’s Covid vaccine basket consists primarily of Covishield (developed by AstraZeneca and manufactured by the Serum Institute) and Bharat Biotech’s Covaxin.