Edvince AB was granted FDA Orphan-Drug Designation for EDV2209 in treatment of subarachnoid hemorrhage
Edvince AB, a biotech company that is developing a new treatment concept to minimize brain damage subsequent to cerebral ischemia, received a positive response from the US Food and Drug Administration (FDA) on august 3rd, granting the EDV2209 drug orphan-drug designation for treatment of subarachnoid hemorrhage.
Orphan-drug designation can in the USA be granted for treatments targeting diseases with less than 200,000 patients yearly. Orphan-drug designation status for a drug is valuable, and comes with many developmental and market benefits. For example, development cost tax incentives and clinical research financial subsidies are available. Most importantly, an orphan-drug will receive a 7-year market exclusivity after a formal market approval.
- We are very happy to receive this positive response from the FDA. It is an important milestone in the development the EDV2209, and greatly speeds up the time to reach patients and make a difference, says Carl-Magnus Högerkorp, CEO Edvince AB.
Subarachnoid hemorrhage is a condition that affects around 100,000 individuals every year, in Europe and the USA. EDV2209 is a drug under development for the treatment of delayed cerebral ischemic events, which is the leading cause of brain damage in subarachnoid hemorrhage.
For more information, please contact:
Carl Magnus Högerkorp, CEO, telephone: +46 (0)70-3105340
Cristina Glad, Chairperson, telephone: +46 (0)70-6602433
Edvince AB is a biotech company that develops a new treatment concept for brain damage caused by cerebral ischemia, which occurs in all types of stroke. The company is currently in the preclinical phase and aims to initiate its first clinical study in late 2017. The company is based at SmiLe Incubator in Lund 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.