Medicines and Healthcare products Regulatory Agency
MSD (known as Merck & Co Inc. in the United States and Canada) worked with the MHRA (Medicines and Healthcare products Regulatory Agency) to take the new skin cancer treatment pembrolizumab through the early access to medicines scheme (EAMS). The successful application has led to over 500 patients with advanced melanoma benefiting from the breakthrough treatment before being licensed.
Pembrolizumab was the first medicine to be awarded a positive scientific opinion, which helped to accelerate access to the drug by around 4 months.
Ben Lucas, Business Unit Director, Oncology, MSD said:
EAMS undoubtedly accelerated access to pembrolizumab for patients with advanced melanoma and demonstrates a world-leading example of how healthcare agencies and industry can work together to get treatments to patients more quickly.
EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that are not licensed yet when there is a clear unmet medical need. See our guidance on EAMS for more information.
Dr Siu Ping Lam, Director of Licensing, MHRA said:
EAMS is an important step in ensuring patients gain access to innovative medicines as soon as possible, improving health outcomes in patients that urgently need new treatments.
MSDs decision to submit Pembrolizumab meant that we awarded our first positive opinion ahead of a licensing decision, thoroughly tested EAMS principles and processes, and learned much along the way.
Speeding up patient access to new, promising, innovative treatments is a current priority for UK government, regulatory agencies and the pharmaceutical industry.