ICER considers hemophilia drug values against backdrop of costly factor VIII prices
The USA's Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of BioMarin Pharmaceutical’s (Nasdaq: BMRN) Roctavian (valoctocogene roxaparvovec) and Roche’s (ROG: SIX) Hemlibra (emicizumab) for the treatment of hemophilia A.
In August 2020, BioMarin received a Complete Response Letter from the US Food and Drug Administration (FDA) requesting an additional two years of follow-up safety and efficacy data on valoctocogene roxaparvovec, and that process may delay the gene therapy’s approval decision in the USA until at least 2022.
'Possibility of a cure on the horizon'
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