The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS). EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need.
The MHRA issued the scientific option to Bristol-Myers Squibb Pharmaceutical Limited for its advanced melanoma product, nivolumab. Nivolumab represents the second medicine, and also the second anti-PD-L-1 monoclonal antibody, to be approved as part of the EAMS. In March this year, Merck Sharp & Dohme Limited’s product, pembrolizumab, used to treat advanced melanoma received the first EAMS scientific opinion. The scientific opinions comprise a public assessment report and three treatment protocols, for patients, healthcare professionals, and on the pharmacovigilance system. Both opinions describe the risks and benefits of the medicines and the context for their use, supporting the prescriber and patient to make a decision on whether to use either medicine before their licence is granted.
An EAMS scientific opinion represents the second evaluation stage for approval of a medicinal product for access under the EAMS. The first phase relates to the MHRA assessing whether an applicant can establish that a medicinal product fulfils the 3 criteria for a promising innovative medicine (PIM) designation, i.e., that:
(1) the product is intended for the diagnosis, prevention or treatment of a life-threatening or seriously debilitating condition with high unmet need; and
(2) the product is likely to offer major advantage over methods currently used in the UK; and
(3) the potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
Once a PIM designation is obtained, an applicant moves onto the second evaluation phase, which involves the MHRA issuing a scientific opinion on the benefit/risk balance of the medicine. The MHRA adopts the scientific opinion based on a dossier submitted by an applicant containing documentation on quality, non-clinical and clinical data, conditions of use, pharmacovigilance requirements, risk management plan, and a patient registry. Once the opinion is adopted it is made publicly available on the MHRA website. EAMS scientific opinions last for one year, but can be renewed. More information on the EAMS is available on the MHRA website here.