Edvince AB granted EU Orphan Medicinal Product Designation for EDV2209 in treatment of non-traumatic subarachnoid hemorrhage
On November 8th Edvince AB received a positive decision from the European Commission, granting the EDV2209 drug Orphan Medicinal Product Designation for treatment of non-traumatic subarachnoid hemorrhage.
Edvince AB is a Life Science R&D company that develops a new treatment to minimize brain damage in patients that has suffered a bleeding in the brain – subarachnoid hemorrhage – caused by brain aneurysm.
Orphan medicinal product designation can be granted by the European Commission for diseases with a prevalence of less than 5 individuals per 10,000. Orphan medicinal product designation status for a drug is valuable, and comes with many developmental and market benefits. For example, a prioritized and subsidized regulatory process with the European Medicines Agency (EMA) is available. Most importantly, orphan designation implies a potential for up to 12 years exclusivity on the European market after a formal market approval.
- We are extremely happy to receive this positive response from EMA and the European Commission. Along with the orphan designation granted by the FDA in august 2017, this is a very important milestone in the development of a new treatment for subarachnoid hemorrhage. Since Edvince is committed to bring this therapy to patients in need, the orphan medicinal product designation will accelerate and facilitate this process, says Carl-Magnus Högerkorp, CEO, Edvince.
Subarachnoid hemorrhage is a condition that affects around 50 000 individuals every year in Europe, typically as a consequence of a ruptured brain aneurysm, leading to a bleeding in the brain. There is a huge unmet medical need in the management of subarachnoid hemorrhage. Up to 40-50% dies and 3 out of 5 that survives will not return to a normal life. Subarachnoid hemorrhage triggers events that days later will affect the blood supply to parts of the brain resulting in brain damage. EDV2209 prevents these events from occurring and maintains the blood supply to the brain.
For more information, please contact:
Carl Magnus Högerkorp, CEO, telephone: +46 (0)70-3105340, email: firstname.lastname@example.org
Cristina Glad, Chairperson, telephone: +46 (0)70-6602433
Edvince AB is founded on the research from Professor Lars Edvinsson and his team, having world-class insight in what happens in the blood vessels of the brain during a stroke. Edvince develops a new drug treatment with great potential to minimize brain damage caused by cerebral ischemia, which occurs in all types of stroke. Edvince will initiate the first clinical trials with EDV2209 in subarachnoid hemorrhage during the coming year. The company is based at SmiLe Incubator in Lund, Sweden and is owned by its founder, Lars Edvinsson, as well as the Krankajen Group, Almi Invest Syd, the Swedish Growth Fund, LMK Forward and Sarah Fredriksson.