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Another EU Filing Targets Burgeoning NMOSD Market

 
• By Neena Brizmohun

Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.

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EU regulators are starting to review Viela's marketing application for inebilizumab • Source: Shutterstock

Inebilizumab, Viela Bio’s orphan drug for treating the rare neuroinflammatory autoimmune disease, neuromyelitis optica spectrum disorder (NMOSD), is among the latest batch of products that the European Medicines Agency is starting to review for pan-EU approval.

Inebilizumab, which was approved in the US last June as Uplizna, is targeting a burgeoning market.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.