Wednesday 16 October 2019

Mainstay Medical has pre-market approval application accepted by FDA

Joe Wiley, CEO of Irish pharma firm Amryt
Joe Wiley, CEO of Irish pharma firm Amryt
Ellie Donnelly

Ellie Donnelly

Mainstay Medical, which is focused on developing a product - ReActiv8 - to treat chronic lower back pain, has had its Pre-Market Approval (PMA) application for ReActiv8 accepted by the US Food and Drug Administration (FDA).

Mainstay expects a decision on approval around the end of next year.

Elsewhere, 'bad cholesterol' drug firm Amryt Pharma said the FDA has designated the investigation of AP101 (Oleogel-S10) for the treatment of Epidermolysis Bullosa (EB) as a fast track development program. EB is a condition that weakens the skin and makes it prone to blistering.

The fast track programme is designed to accelerate the development and review of products such as AP101, which are intended to treat serious diseases and for which there is an unmet medical need. 

Commenting on the FDA’s decision, Dr Joe Wiley, CEO of Amryt Pharma, said: "Receiving a fast track designation from the FDA represents another significant step in the progress of our lead development asset - AP101 - as a potential treatment for the wound related complications of EB, a rare and life limiting condition.”

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