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UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims

According to Starpharma, LloydsPharmacy has paused sales of Starpharma’s Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned “promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorization.” The company said that Viraleze continues to be available in Europe and that it is “rapidly progressing commercial and supply arrangements for the Indian market.”

In September 2020, Starpharma announced that astodrimer sodium nasal spray almost completely inactivated the SARS-CoV-2 virus in studies conducted by the Scripps Research Institute. Starpharma announced in March 2021 that it had signed a sales and distribution agreement with LloydsPharmacy. The company had announced in February 2021 that Viraleze had been approved for sale in the UK and Europe.

Starpharma added that it agreed to the pause in the UK despite the fact that it “disagrees with the MHRA’s position.” In its announcement, the company asserted that it has “extensive data . . . supporting the product and its promotional claims” and noted that “During development and prior to the launch of Viraleze, Starpharma obtained expert regulatory advice and input from an EU regulatory body in relation to the product and its claims.” 

Read the Starpharma press release.

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published on June 25, 2021

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