US pharma giant Merck & Co (NYSE:MRK) revealed yesterday that its anti-PD-1 therapy, pembrolizumab, which is marketed in the USA under the name Keytruda, is the first treatment to be accepted under the UK’s new Early Access to Medicines Scheme (EAMS).
Pembrolizumab was accepted under the scheme for the treatment of advanced melanoma based on the significance of the early study findings and unmet medical need. Pembrolizumab received the Promising Innovative Medicine (PIM) designation in the UK, on October 10, 2014. An application for European Medicines agency approval was made in June 2014 and a decision is pending.
In 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) introduced the EAMS to help patients benefit from promising, innovative treatments before a European license has been granted.
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