PRIME TIME: Reflecting on the first 5 years of the EMA’s PRIority MEdicines scheme
It's hard to fathom that five years have passed since the European Medicines Agency (EMA) adopted the PRIority MEdicine (PRIME) scheme. In March 2016, PRIME was received with high expectations for greater speed of access for patients in Europe. On this five-year anniversary, I’d like to offer several reflections on PRIME from the viewpoint of one innovative pharmaceutical company that has not had a PRIME-designated product to date. (Note: Based on public information from EMA's monthly PRIME reports).
According to their website, the EMA launched PRIME "to enhance support for the development of medicines that target an unmet medical need" and "to optimise development plans and speed up evaluation so these medicines can reach patients earlier." At the time, we, as Lilly, along with the EU’s innovative pharmaceutical industry applauded this new initiative. In an article for EFPIA, I remarked that the hope is to translate advances in scientific research into accessible patient treatments more efficiently and effectively than in the past. Although there are differences, many compared the PRIME concept to that of the US Food and Drug Administration's (FDA's) breakthrough therapy designation (BTD), which speeds the FDA’s review process for specific products that address serious unmet medical needs.
5 years passed in the blink of an eye
In our industry, five years can disappear in the blink of an eye. It takes, on average, 10 years to develop and gain the approval of every new medicine that eventually reaches patients. Lilly has strived for continued innovation in diabetes care for almost 100 years since we introduced the world's first commercial insulin. For the last 30 years, Lilly has persisted in our efforts to research and develop innovative Alzheimer’s diagnostics and therapies.
5 years can feel like a lifetime to a patient
Yet, in other ways, five years can seem like a lifetime if you or a loved one is awaiting a medical advance to offer hope for an unmet medical need. The International Diabetes Federation estimates that in 2019, approximately 463 million adults (20-79 years) were living with diabetes around the world and by 2045 this will rise to 700 million. Alzheimer Europe estimates that the numbers of people with dementia living in Europe will almost double by 2050, with nearly 19 million people living with the condition.
A milestone for reflection
Because new medicines bring new hope, we have keenly followed the EMA's PRIME scheme since its inception. Lilly has always pushed the boundaries of science to make conditions that are incurable today, treatable tomorrow. To date, the EMA has received around 335 applications for PRIME consideration from large and small companies and academia. Of those, 24% or 84 products have been accepted into the PRIME scheme. 1 Conversely, the FDA has received twice as many BTD requests over the last five years, accepting 43% of applications. 2 In the past five years, Lilly has been granted five FDA BTDs.
PRIME’s next 5 years
Just last year, the EMA released its Regulatory Science Strategy to 2025 explaining that the “pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines.” To deliver on its strategy, the EMA intends to "promote and invest in the PRIME scheme," and hence, incorporated six specific PRIME actions, including to:
Optimise the current regulatory system that supports PRIME in order to enable a shortened time frame for development and marketing application review while ensuring high quality evidence generation plans to improve access for patients
Explore possible impact and benefits of expanding the earliest possible entry to the PRIME scheme to a wider range of applicants, including for new indications of existing products
Lilly would welcome these continued PRIME scheme policy enhancements. Though PRIME has already offered undeniable value for patients, we foresee even greater promise that PRIME could deliver. We should apply the learnings that have presented speedier R&D and regulatory actions during the battle against the global COVID-19 pandemic. This is the scheme’s optimal moment in time, or I should more accurately say, it's "PRIME TIME!"
References
European Medicines Agency. (2021, March 3). Recommendations on eligibility to PRIME
scheme. https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-22-25-february-2021_en.pdfFrom fiscal year 2016 to 2020, CDER and CBER received a combined 738 applications for breakthrough therapy designation and accepted 315 of those applications: https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals; https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
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