Merck Sharp & Dohme LLC - 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

“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 — 6 supporting sources.

Score 806 references

Featured Reference

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

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.

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.

Merck Confirms Agreement with UNICEF to Establish the World’s First Global Ebola Vaccine Stockpile with ERVEBO® (Ebola Zaire Vaccine, Live) - Merck.comSource

Since the outbreak began in the Democratic Republic of the Congo in 2018, Merck has donated more than 305,0001.0 mL investigational doses of the vaccine to the response efforts under the auspices of an Expanded Access protocol.

KOSELUGO® (selumetinib) Approved by FDA for Pediatric Patients Two Years and Older With Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas - Merck.comSource

Decreased LVEF resulting in permanent discontinuation of KOSELUGO occurred in a pediatric population with NF1 in an expanded access program.

Smallpox - Infectious Diseases - Merck Manual Professional EditionSource

The antiviral drug tecovirimat: Approved by the US Food and Drug Administration [FDA] for the treatment of smallpox—available in oral and IV formulations from the CDC via an Expanded Access Investigational New Drug (IND) protocol for the primary or early empiric treatment of mpox in all ages; approved for smallpox and mpox in the European Union

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 6 supporting sources.

Score 406 references

Featured Reference

Post Marketing Surveillance Study of CuprimineOpens in new window

Conditions: Scleroderma

Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)Source

Conditions: HIV Infections

Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular AnomaliesSource

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

Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)Source

Conditions: Mycoses

Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)Source

Conditions: Melanoma

Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)Source

Conditions: Lymphoma, T-Cell, Cutaneous

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