PRIME is a program set up by EMA to support the development of medicines for which there is an unmet medical need. This voluntary program is based on increased interaction and early dialogue with the developers of promising drugs, and is designed to streamline development plans and accelerate evaluation, potentially bringing those drugs to patients sooner. According to EMA, developers of medicines eligible for PRIME can expect additional opportunities for scientific advice and are entitled to an accelerated evaluation at the time of applying for marketing authorisation.
NicaPlant was already classified as an orphan drug by the EMA during its development in 2019. “Promising results from non-clinical data as well as safety, tolerability and efficacy in Phase 2a and b patients formed the basis of the application for PRIME approval. We are pleased with the EMA's decision to grant NicaPlant PRIME approval. We look forward to leveraging the benefits of PRIME to further advance our program," said Dr. Tiziana Adage, Chief Scientific Officer of BIT Pharma.
Aneurysmal subarachnoid hemorrhage (aSAH), which accounts for up to 98,9% of all non-traumatic subarachnoid hemorrhages, is associated with a high patient mortality rate (>40%), high survivor disability (30% at three months), and only 60% of survivors are able to resume their previous lifestyles after six months, imposing lifetime costs on the healthcare system and a burden on patients and their families.
In a phase 2a clinical study on patients, NicaPlant® proved to be safe and well tolerated at all doses examined. In a phase 2b clinical study, the effectiveness of NicaPlant® on the occurrence of cerebral angiographic vascular spasms after aneurysmal subarachnoid hemorrhage (aSAH) was examined. The NicaPlant® implants did not raise any safety concerns and had a significant positive effect on reducing the incidence of vasospasm and the need for anti-vasospasm rescue therapy, among other positive results.
