Thursday, March 12, 2015

KEYTRUDA is available to patients through U.K. Early Access to Medicines Scheme

“This news will be greatly received by the melanoma community in the U.K. At the moment, there are limited options for advanced melanoma patients, the majority of whom are in difficult positions which simply means they cannot afford to play any kind of waiting game,” said Gillian Nuttall, Melanoma UK. “We welcome early access to this treatment for advanced patients made possible through this new scheme. There is clearly an unmet need and we are delighted such progress is being made.”
“We welcome the Government’s proactive approach in facilitating early access to medicines for critically ill patients and are delighted that pembrolizumab will be the first innovative medicine to be available to patients through the Early Access to Medicines Scheme,” said Mike Nally, managing director for MSD UK and Ireland.
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.
The U.K. EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need. Under the scheme, the MHRA will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made. The opinion lasts for a year and can be renewed. 

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