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Fig. 2 | Orphanet Journal of Rare Diseases

Fig. 2

From: The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis

Fig. 2

Chronogram of the marketing authorization and the extension of indications of LUM/IVA (a), TEZ/IVA (b) and ELX/TEZ/IVA (c) in the US and in the EU. Extensions of common indications FDA-EMA have been granted first by the FDA: LUM/IVA, 2 extensions in common, median 10.5 months (5.4–15.6); TEZ/IVA, 1 extension in common, 17.4 months before

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Orphanet Journal of Rare Diseases

ISSN: 1750-1172