Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 132

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 132
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Accelerated Approval Pathway

The FDA may grant accelerated approval to
a product candidate designed to treat a serious or life-threatening condition that provides a meaningful therapeutic advantage to patients
over existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely
to predict clinical benefit. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement,
radiographic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical
benefit. The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical
endpoint that can be measured earlier than an effect on irreversible morbidity or mortality (“IMM”), and that is reasonably
likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition
and the availability or lack of alternative treatments.

The accelerated approval pathway is most often
used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical
benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Products granted accelerated
approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

The FDA’s approval of a candidate product
under the accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct post-approval confirmatory studies
to verify and describe the product’s clinical benefit, and the FDA may require such studies to be underway prior to approval. Failure
to conduct required post-approval studies, confirm a clinical benefit during post-marketing studies may result in the FDA’s withdrawal
of the product from the market on an expedited basis. All promotional materials for therapeutic candidates approved under accelerated
regulations are subject to prior review by the FDA.

Orphan Drug Designation and Exclusivity

Orphan drug designation in the United States
is designed to encourage sponsors to develop products intended for treatment of rare diseases or conditions. In the United States, a
rare disease or condition is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that
affects 200,000 or more individuals in the United States and for which there is no reasonable expectation that the cost of developing
and making available the drug or biologic for the disease or condition will be recovered from sales of the product in the United
States.

Orphan