Genmab — Maj 2021
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Thanks EL - seems this is the pertinent part: The variable nature of the EGFR mutations in the proposed condition and the overlap with other oncological conditions with EGFR alterations could not be clarified by the sponsor thus raising doubts about the distinctiveness of the proposed condition. There are no international classifications that define the proposed condition as unique.
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It’s the EGFR “subset” of nscl that cannot be considered well-defined
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I do find the EMA argumentation a bit confusing
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Sponsors who obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview
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i agree it is mainly about market exclusivity , but i do think that can be important with the rapid development of copy cats and generics. But i agree that it would only be for a small part of the market they may eventually target, as we know that they wouldn't get orphan for the whole NSCLC indication (if they decide to go for that broader label)
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Go morgen.
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Onsdagens aviser med Pandora, Jyske Bank og Huscompaniet https://www.proinvestor.com/investornyt/674730/onsdagens-aviser-med-pandora-jyske-bank-og-huscompaniet
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