Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 148

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 148
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) that the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition,
where either (i) such condition affects not more than five in ten thousand persons in the EU when the application is made, or (ii) without
incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment
in its development, and (2) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question
that has been authorized in the EU or, if such method exists, the drug will be of significant benefit to those affected by that condition.
In the UK, the MHRA conducts an equivalent assessment, against criteria which have been tailored for the UK population.

The COMP is required to re-assess the granted
orphan designation at the time of marketing authorization grant to ensure that it continues to meet the criteria for the designation
to be maintained. Otherwise, the orphan designation can be revoked. In relation to the UK, the MHRA does not grant orphan designations
during the development of the medicinal product. Instead, the MHRA will decide whether the criteria are satisfied at the point of marketing
authorization grant. An orphan drug designation provides a number of benefits, including fee reductions, fee waivers, protocol assistance
(as a type of scientific advice specific for orphan medicinal products) and the possibility to apply for a centralized EU marketing authorization.
Marketing authorization for an orphan medicinal product benefits from a ten-year period of market exclusivity. During this period of
market exclusivity, the European Commission, national competent authorities of the EU member states may only grant marketing authorization
to a “similar medicinal product” for the same therapeutic indication if: (i) a second applicant can establish that its
medicinal product, although similar to the authorized product, is safer, more effective or otherwise clinically superior; (ii) the
marketing authorization holder for the authorized product consents to a second orphan medicinal product application; or (iii) the
marketing authorization holder for the authorized product cannot supply enough orphan medicinal product. A “similar medicinal product”
is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal
product, and which is intended for the same therapeutic indication. The period of marketing protection for the authorized therapeutic
indication may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer
meets the criteria for orphan drug