Introducing a Hormonal Based Medicinal Product
This large EU-based pharmaceutical organization wanted to introduce its combined hormonal-based medicinal product that provides targeted treatment delivery in a constant concentration to the market. Involving a complex drug-and-device combined product licensing scenario, the organization needed an integrated regulatory strategy to support its simultaneous entry into EU and US markets.
Looking to launch in the assisted reproductive technologies market, this organization had developed an intravaginal ring that releases a hormone-based medication to enhance fertility. Eliminating the need for frequent administration regimes typically associated with oral dosing or injection, this advanced reproductive health technology product is designed to enable a controlled release regime.
As a solid polymeric carrier developed for urogenital use, the organization knew there would be intense scrutiny of multiple aspects of the product submission. Indeed, the introduction of a combined product in this field is a demanding process; alongside clinical submissions, comprehensive safety requirements relating to the device materials need to be satisfied.
The organization wanted to avoid undertaking extended clinical trials, as this would represent a significant additional time and cost burden. However, the preparation of an integrated EU and US regulatory strategy was complicated: while in the US the product would be filed as a generic, in a select number of EU markets the combined drug and device product would require a full application.
ELC Group solution
With extensive experience in drug and device applications, and a deep understanding of the EU regulatory landscape, ELC Group’s experts set about devising a justification approach that would avoid the need for extended clinical studies and demonstrate device material quality. To support the fast tracking of filing applications, ELC Group set about identifying a number of potential comparable clinical studies for inclusion in submissions. The comprehensive approach recommended by ELC Group also incorporated the preparation of a legal basis to demonstrate that the product represented a ‘hyper generic’ to selected Competent Authorities.
The licensing complexity relating to a combined product of this nature meant that ELC Group needed to build a comprehensive justification case on multiple fronts; designed to contain hormones, elastomeric IV rings typically feature a matrix (homogeneous dispersion), a reservoir (core) and a sandwich (shell), and enable the slow diffusion of treatments. With this in mind, it prepared an initial case and requested a high level scientific advisory meeting with a major European Regulatory Agency, acting as the organization’s representative at this event.
The extensive output resulting from this advisory discussion enabled ELC Group to determine the best approach to conducting clinical studies that would minimize time and cost for its client. This included identifying a comparable product to which a Phase III study could be designed for comparison to standard treatment (and placebo) purposes.
To address the complex submission landscape requirement, ELC Group selected a community of agencies to enter detailed discussions with, establishing a regulatory pathway framework for individual territories that incorporated strategies for full, mixed or hybrid applications.
The ELC Group solution included:
- Creation of an integrated EU and US regulatory strategy.
- Preparation of bibliography justifications for toxicity and clinical studies.
- Identification and recommendation of a comparable Reference Listed Drug (RLD) to support US submission.
- Identification and preparation of a legal basis for applications.
- Facilitating a scientific advice meeting with the MHRA in the UK, a regulator with extensive experience of a product of this nature.
- ELC Group was able to implement a positive clinical development strategy to demonstrate the product is safe and performs as intended in a clinically meaningful and cost-effective way.
- ELC Group’s experienced clinical services team worked with the client to identify the best data measurements to implement in clinical trials that would support an integrated US/EU licensing approach.
- The combined product is currently undergoing application processes in multiple European countries and the US.