The FDA and EMA have similar views and processes on drug approvals. With our nod to move forward with a complete MA, it’s hard to believe the FDA would view our data so differently.
With two reg bodies giving us the go ahead, the SP should react accordingly. Missling would not go to the FDA if Kun said we are not ready. Kun’s view holds a lot of weight and most likely helps to drive Missling’s decisions.
The European Medicines Agency (EMA) may recommend a company pursue a complete marketing authorization (MA) rather than a conditional MA for several reasons, depending on the specific circumstances and characteristics of the medicinal product. Here are some potential reasons why the EMA might make such a recommendation:
1. Adequate Benefit-Risk Profile: The EMA may determine that the benefit-risk profile of the medicinal product is sufficiently well-established to support a full MA, without the need for additional data or conditions. This could be the case if the product has demonstrated significant clinical benefits with an acceptable safety profile in pivotal clinical trials.
2. Robust Clinical Data: The EMA may have reviewed comprehensive and robust clinical trial data demonstrating the efficacy, safety, and quality of the medicinal product, providing confidence in its overall benefit-risk assessment.
3. Unmet Medical Need: If the medicinal product addresses an unmet medical need or provides a significant therapeutic advance in treating a particular disease or condition, the EMA may prioritize granting a full MA to ensure timely access for patients.
4. Manufacturing and Quality Assurance: The EMA may assess that the manufacturing and quality control processes for the medicinal product meet the necessary standards for ensuring consistent quality and safety, supporting a full MA.
5. Public Health Considerations: In some cases, granting a full MA may be deemed more appropriate from a public health perspective, particularly if the product addresses a significant public health issue or if conditional approval could introduce uncertainty or risks for patients.
It's important to note that the decision to grant a full or conditional MA is based on a comprehensive evaluation of scientific data, regulatory criteria, and public health considerations by the EMA. The agency aims to make decisions that balance the need for timely access to medicines with the requirement for robust evidence of efficacy, safety, and quality.
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