Vaginal probiotics quietly making progress in drug reclassification in the EU

Original Source: Sandwalk Bioventures

The Spanish Medicines Agency (AEMPS) just authorized its first-ever drug based on live microorganisms for vaginal application. Muvagyn®, containing live L. gasseri and L. rhamnosus, is indicated for the normalisation of the altered vaginal microbiota after antibiotic treatment of bacterial vaginosis and to maintain a normal vaginal microbiota in case of recurrent vaginal infections. This is the first product of this kind successfully repositioned as a pharmaceutical from its former medical device status in the country. This same product, under the name Vagisan ProbioFlora®, had also been reclassified as a drug in Germany in 2022.

Products containing live microbes to treat vaginal infections and similar conditions have existed in Europe for decades. However, regulatory discrepancies existed: Whereas many of them were marketed as drugs, some were registered as medical devices. Sometimes even the same product held distinct regulatory categories in different EU countries.

This led to disputes between companies and between different EU national authorities. After some of these cases escalated up to the Court of Justice of the European Union, the regulatory framework for medical devices in Europe was updated, taking all products containing live microbes out of the scope of medical devices and leaving vaginal probiotics formerly registered as medical devices without a legal home – or a clear route to market.

News coming from Spain and Germany are therefore relieving for companies in the field of vaginal probiotics, and also for every company developing microbiome-based drugs, as lack of clear drug regulatory pathways is an overarching concern in this sector.

Outside the EU, but within the EEA, Softigyn®, a vaginal product containing L. plantarum, was approved in 2022 by the Swiss Authorities based on the existence of a medicinal product containing the same active substance for a comparable indication in Italy for over 10 years.

Luis Gosálbez
Managing Director at Sandwalk BioVentures

Sandwalk BioVentures is a specialty strategy, innovation, regulatory and management consulting firm focused on microbiome technologies servicing companies in the food and pharma sectors, as well as financial and strategic investors exploring to enter this field. The company has created the Microbiome Drug Database™, an online repository containing the most extensive and thorough analysis of biotechnology companies developing pharmaceuticals from or through the microbiome.