NICE recommends Aspaveli ahead of MHRA decision

9 December 2021

The UK's National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Decision (FAD) recommending the use of Aspaveli (pegcetacoplan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) in England and Wales.

The NICE’s FAD has been published following a Fast Track Appraisal and recommends the Swedish Orphan Biovitrum (STO: SOBI) drug as an option for treating adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months, once licensed in the UK.

"An important milestone for people living with PNH in England and Wales"Aspaveli, which is branded as Empaveli in the USA, is currently undergoing assessment with the Medicines and Healthcare products Regulatory Agency (MHRA) for a marketing authorization in the UK.

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