The MHRA has published official statistics on its Early Access to Medicines Scheme ("EAMS"). The published tables show that 27 applications were made to EAMS for the promising innovative medicine designation and the scientific opinion. The tables also show the number of applications that have been granted (17) and refused (four), as well as the number of pending (five) applications. The scheme, which was launched in 2014, 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. The first drug to be approved through EAMS was pembrolizumab for the treatment of advanced melanoma in March 2015 (see previous Jones Day Update).
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