As part of Bionical Emas’ ‘4 things to think about’ series, we outline how Bionical Emas can help clients speed up the development process for promising new medicines for patients whose diseases cannot be treated, or who need better treatment options.
The European Medicines Agency (EMA) recently launched the PRIME (PRIority Medicines) scheme which is focused on medicines that target an unmet medical need (e.g. rare cancers, dementias) and offers early and enhanced support to medicine developers. Once a medicine has been selected for PRIME, the successful applicant will be assigned a EMA contact person and an expert from one of the EMA’s scientific committees who will advise on the need for and timing of scientific advice as well as offer general guidance. Full support will be offered at every stage through to marketing approval. Eligibility to the scheme leads to an accelerated assessment timetable at marketing authorisation application (MAA).
1. Who can apply?
The PRIME scheme is open to all medicines developers but is particularly targeted at micro, small and medium-sized enterprises (SMEs) and applicants from the academic sector. Bionical Emas will establish whether a client meets the eligibility criteria for SME status. SMEs and academic institutions in particular can benefit from earlier scientific and regulatory support since they often lack experience with the regulatory framework.
2. When can we apply?
SMEs and applicants from the academic sector can apply for PRIME at an earlier stage of development if they have compelling non-clinical data and tolerability data from initial clinical trials (i.e. proof of principle). Other applicants will need to have some compelling exploratory data showing clinical efficacy and safety data in patients (prior to phase III/confirmatory clinical studies).
3. How do we establish ‘Unmet medical need’?
The extent to which the medicinal product is expected to address the unmet medical need is essential to its eligibility for PRIME support. We will help you to develop compelling arguments focused on the following points:
- Epidemiology: We will assess the epidemiology of the target indication with a view to clearly defining life expectancy, symptoms and duration, health-related quality of life and related matters
- Other available treatments: We will look at other available treatments and will formulate arguments around how the medical need is not fulfilled by the available methods.
- Potential for the medicinal product to significantly address the unmet medical need: We will conduct a thorough review of your existing non-clinical and clinical data package with the aim of building arguments centred around the medicinal product’s observed and predicted effects, the clinical relevance, the added value of the medicinal product and its impact on medical practice.
We will finalise, publish and submit the application on your behalf, and will act as the point of contact during the EMA’s assessment of your application.
4. How long before a decision?
You will find out whether you are eligible for PRIME support within ~ 7 weeks of submitting your application. The PRIME assessment timetable and outcome are published on the EMA website.
How Bionical Emas can help
Bionical Emas regulatory team will first establish whether you meet SME eligibility criteria. After reviewing the available data to confirm suitability for PRIME support, we will complete and submit a PRIME application to the EMA on your behalf. We will diligently coordinate all subsequent interactions with the EMA from the start of the process and guide you right through to final approval of the application.
If you would like to talk to one of experts or discuss how Bionical Emas can support your development program then please do contact us at firstname.lastname@example.org