Information on ogsiveo?

What is Ogsiveo?

Ogsiveo (nirogacestat) is an oral gamma secretase inhibitor approved by the FDA in November 2023 for treating adults with desmoid tumors that can't be removed by surgery.[1] Desmoid tumors are rare, non-cancerous growths that arise from connective tissue and can cause pain or organ damage.

How does Ogsiveo work?

It blocks gamma secretase, an enzyme that activates Notch signaling, which fuels desmoid tumor growth. In clinical trials, this shrank tumors in about 41% of patients, with 7% achieving complete response.[1][2]

Who makes Ogsiveo and what's the pricing?

SpringWorks Therapeutics developed and markets Ogsiveo. The wholesale acquisition cost is $27,000 per month, though patient assistance programs may reduce out-of-pocket costs.[3]

When does Ogsiveo patent protection end?

Core composition of matter patent US10993921 expires in 2040, with additional patents on methods of use extending to 2041. Pediatric exclusivity adds six months to some expirations.4 No generic or biosimilar challenges filed as of late 2024.

[1]: FDA Approval Summary
[2]: NEJM Trial Data
[3]: SpringWorks Therapeutics