Alexion Win Thwarts Roche’s EU Fast-Track Hopes

Roche hopes that its investigational drug satralizumab for neuromyelitis optica spectrum disorder will win EU approval in the second half of 2020.

Hourglass
EU filing for satralizumab has reverted to the standard review timeline • Source: PS141712

Roche has lost the fast track status it won for the EU marketing application it filed with the European Medicines Agency last October for satralizumab, the drug it is developing to treat the rare disease neuromyelitis optica spectrum disorder (NMOSD).

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