Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 49

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 49
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alexion-pays-100m-for-rhythm-s-speedy-review-voucher.

24

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. Surrogate endpoints can often be measured more easily or more rapidly
than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely
to predict the clinical benefit of a drug, such as an effect on IMM. There is limited experience with accelerated approvals by the FDA
based on intermediate clinical endpoints. However, the FDA has indicated that such endpoints generally may support accelerated approval
where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is
a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate clinical benefit of a drug.

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 drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Thus, accelerated approval has
been used extensively in the development and approval of drugs for treatment of a variety of cancers in which the goal of therapy is
generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large
trials to demonstrate a clinical or survival benefit.

The accelerated approval pathway is usually contingent
on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe
the drug’s clinical benefit. As a result, a drug candidate approved on this basis is subject to rigorous post-marketing compliance
requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure
to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw
the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations
are subject to prior review by the FDA.

The FDA’s Decision on an NDA 

On the basis of the FDA’s evaluation of
the NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval
letter or a complete response letter. An approval letter authorizes