Sarepta’s eteplirsen spurned as European regulators turn thumbs down on controversial Duchenne MD drug

Sarepta’s eteplirsen spurned as European regulators turn thumbs down on controversial Duchenne MD drug

Source: 
Endpoints
snippet: 

Sarepta’s approval for eteplirsen — or Exondys51 — in the US remains one of the most controversial OKs in FDA history, earning a rare label that says the biotech has yet to produce evidence the drug works.

But lightning won’t strike twice on the regulatory pathway for this biotech.