NOVO — Ozempic FDA Review (NDA213051, ORIG 1, 2019)

NOVO · 2019 · FDA Review (openFDA)

Report summary

The FDA Clinical Review recommends approval for Novo Nordisk's oral semaglutide (Rybelsus, NDA 213051) for improving glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise. The recommendation is based on the comprehensive PIONEER clinical development program (PIONEER 1-10), which demonstrated the drug's efficacy in reducing HbA1c and body weight, and its safety profile, consistent with other GLP-1 receptor agonists. While gastrointestinal adverse events were common and dose-dependent, leading to higher discontinuation rates, serious adverse events and cardiovascular risk were balanced with comparators. The oral formulation, enabled by the novel excipient SNAC, offers potential for increased patient compliance. Financial disclosures of investigators were reviewed and deemed acceptable.

Key findings — cited to the page

Application Number	213051	Oral Semaglutide (Rybelsus) · p.2
Priority or Standard Review	Priority	Oral Semaglutide (Rybelsus) · p.2
Submit Date	March 20, 2019	Oral Semaglutide (Rybelsus) · p.2
Received Date	March 20, 2019	Oral Semaglutide (Rybelsus) · p.2
PDUFA Goal Date	September 20, 2019	Oral Semaglutide (Rybelsus) · p.2
Established/Proper Name	Semaglutide	Oral Semaglutide (Rybelsus) · p.2
Proposed Trade Name	Rybelsus	Oral Semaglutide (Rybelsus) · p.2
Applicant	Novo Nordisk	Oral Semaglutide (Rybelsus) · p.2
Dosage Form	oral	Oral Semaglutide (Rybelsus) · p.2
Applicant Proposed Dosing Regimen	7 mg, 14 mg, orally, once daily	Oral Semaglutide (Rybelsus) · p.2
NDA number	213051	Oral Semaglutide · p.10
Application Type	New Drug Application	Oral Semaglutide (Rybelsus) · p.2

Source: NOVO ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →