Shots:
- The US FDA has accepted the NDA for ralinepag to treat pulmonary arterial hypertension, with PDUFA target action date of Jun 24, 2027
- NDA was supported by the P-III (ADVANCE OUTCOMES) trial assessing ralinepag vs PBO in 687 patients with PAH, where pts who completed the trial had the option to enroll in ongoing ADVANCE EXTENSION OLE study
- Ralinepag met its 1EP, reducing clinical worsening risk by 55% in predominantly pre-treated PAH pts, while enhancing NT-proBNP and 6MWD, along with improving clinical improvement odds by 47%, with consistent benefits across patient subgroups; data were published in The Lancet
Ref: Businesswire | Image: United Therapeutics | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
