Merck & Co. - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

Expanding Access to Merck's Investigational MedicinesOpens in new window

“When results from clinical trials suggest that one of our investigational medicines may offer benefits for patients facing life-threatening conditions, Merck is committed to bringing that medicine to those patients as quickly and equitably as possible. Participation in clinical trials should be the primary route by which patients get access to investigational medicines and contribute to the collection of safety and efficacy data needed to support regulatory approval worldwide, but for patients with a serious or life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an expanded access program may be an option. Depending on country regulations and the program criteria, access to investigational medicines may be provided through Expanded Access Programs (EAP) (known as compassionate use programs in certain jurisdictions).”

EAP Related Articles from Sponsor

Score contribution: 80 — 8 supporting sources.

Score 808 references

Featured Reference

Merck Announces Collaboration to Improve Maternal Health through Expanded Access to Family Planning - Merck.comOpens in new window

Merck and the Bill & Melinda Gates Foundation today announced that they will work together to expand access to family planning, a critical step in improving the health of women around the world.

KEYTRUDA® (pembrolizumab) is First Medicine to be Made Available to Patients Through U.K. Early Access to Medicines Scheme (EAMS) for Advanced Melanoma - Merck.comSource

To date, more than 3,500 patients in over 40 countries have received early access to pembrolizumab for the treatment of advanced melanoma through the company’s global expanded access program.

Clinical trials - Merck.comSource

Participation in clinical trials is a primary route by which patients get access to investigational medicines and contribute to the collection of safety and efficacy data needed to support regulatory approval worldwide. For patients with a serious or life-threatening condition who are ineligible or unable to participate in a clinical trial, use of an expanded access program may be an option.

Merck Joins In Recognizing Those Who Responded to the Latest Ebola Outbreak - Merck.comSource

Merck, representatives from the WHO, MSF and the DRC government collaborated to supply and support the administration of the investigational V920 Ebola Zaire virus vaccine under WHO’s Expanded Access clinical protocol.

VARIVAX, Merck’s Varicella (Chickenpox) Vaccine, Awarded WHO Pre-Qualification Status - Merck.comSource

WHO pre-qualification allows for expanded access to VARIVAX and provides a greater opportunity to help protect more people from varicella.

KEYTRUDA® (pembrolizumab) Receives New Draft Recommendation from National Institute for Health and Care Excellence (NICE) in U.K. for First-Line Treatment for Advanced Melanoma - Merck.comSource

KEYTRUDA was the first medicine available through the U.K. Early Access to Medicines Scheme (EAMS), which was introduced in the U.K. in 2014 to help patients with life-threatening or seriously debilitating conditions benefit from promising, innovative treatments before a European license has been granted.

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 1 supporting sources.

Score 401 references

Featured Reference

Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular AnomaliesOpens in new window

Conditions: Proteus Syndrome, PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorders

Reagan-Udall Foundation Insights

Company

Merck & Co.

Expanded Access Website

http://www.merck.com/about/views-and-positions/access-to-medicines/home.html

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