Regeneron Pharmaceuticals

Official Statements

Score contribution: 100 — 3 supporting sources.

Score 1003 references

Featured Reference

Regeneron Compassionate Use RequestOpens in new window

“Managed Access Programs (MAPs) are intended for patients with serious or lifethreatening conditions who do not have any viable or available treatment options and are unable to participate in ongoing clinical trials. MAP is a broad term that encompasses multiple types of access programs, including but not limited to "Named Patient”,“Expanded Access","Compassionate Use",and “Early Access."”

Managed Access Program Policy_30JUL24[88]Source

“Managed Access Programs (MAPs) are intended for patients with serious or lifethreatening conditions who do not have any viable or available treatment options and are unable to participate in ongoing clinical trials. MAP is a broad term that encompasses multiple types of access programs, including but not limited to "Named Patient”,“Expanded Access","Compassionate Use",and “Early Access."”

Regeneron Position Statement on Ethics in Clinical StudiesSource

“In exceptional circumstances where there is a clear medical rationale, Regeneron may provide the product candidate to non-study participants prior to marketing authorization and product availability through our Managed Access Program. For more information see our Managed Access Program Policy.”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

Featured Reference

Health Equity & Access to MedicineOpens in new window

Our Managed Access Program gives certain U.S.-based patients who have serious or life-threatening conditions access to a potentially beneficial medicine when no comparable or satisfactory alternative therapy options or clinical trials are available.

Regeneron US Pricing PhilosophySource

Regeneron maintains a Managed Access Program to make certain medicines available to eligible patients before they are commercially available.

Transparency & Policies | RegeneronSource

[Managed Access Program](https://www.regeneron.com/downloads/managed-access-programs.pdf)

Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) InjectionSource

In response to the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), we worked with the World Health Organization (WHO), U.S. FDA and other global organizations to offer Inmazeb under a compassionate use protocol and include it in the four-arm PALM Trial. With BARDA support, we continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries.

Inmazeb Prescribing InformationSource

Overall, 382 adult and pediatric subjects with Orthoebolavirus zairense infection received INMAZEB in one clinical trial (the PALM trial) and as part of an expanded access program conducted in the Democratic Republic of Congo during a Orthoebolavirus zairense outbreak in 2018-2019.