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Mesoblast (ASX:MSB) receives U.S. FDA clearance for remestemcel-L in COVID-19

Health Care
ASX:MSB      MCAP $1.238B
06 April 2020 11:16 (AEST)

Mesoblast (MSB) has received U.S. Food and Drug Administration (FDA) clearance to treat COVID-19 patients with its remestemcel-L product.

In particular, it will be used to treat acute respiratory distress syndrome (ARDS) which is common in patients with COVID-19.

“The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomised controlled trial,” Chief Medical Officer Dr Fred Grossman commented.

Remestemcel-L is an investigational therapy that is made up of mesenchymal stem cells (cells that come from different parts of the body) that are taken from an unrelated donor.

In a recent clinical trial that tested the stem cells against COVID-19 related pneumonia, the treatment was shown to either completely cure or significantly improve functional outcomes for all patients.

Additionally, remestemcel-L has been proven to significantly enhance lung function in patients with chronic obstructive pulmonary disease (COPD), a group of lung diseases that make it difficult to breathe.

Given the similarities between COPD and ARDS caused by COVID-19, Mesoblast has made the connection that remestemcel-L is likely to have a similar outcome on patients with COVID-19 as it did those with COPD.

Originally, remestemcel-L was used to treat steroid-refractory acute versus host. disease, a condition in which the body rejects bone marrow transplants.

This product is now available in Japan under the name Temcell.

Mesoblast has spiked 30.5 per cent on the market this morning and shares are trading for $1.76 each at 10:53 am AEST.

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