Aladote® – regulatory interactions
July 11, 2019
Stockholm, July 11, 2019. Following a meeting request and submission of regulatory documents to U.S. Food and Drug Administration (FDA) in May, PledPharma has been granted a meeting with the FDA at the end of October for advice and discussion on the next Aladote® study and the path to a possible market approval. Advice from the European Medicines Agency, EMA, is expected during the same period.
The meeting in October concerns the next clinical study for Aladote® and the path to a possible market approval of Aladote®, a drug candidate intended to reduce liver damage due to paracetamol poisoning. In March this year, the FDA granted Aladote® an Orphan Drug Designation (ODD). The ODD status is considered to potentially result in shorter development time and a total lower development cost. Furthermore, it includes dedicated support from the FDA during the drug development and seven years of market exclusivity.
In parallel, PledPharma will have a corresponding interaction with the European Medicines Agency, EMA.
“Interactions with the FDA and EMA are important steps for us to optimize the path to market approval. It’s very positive that we have been granted a meeting with the FDA and can now look forward to finalizing the design of the next clinical study. This is an important step towards meeting the medical need of those suffering from paracetamol poisoning and is one of many project activities that we will achieve in the near future,” says Nicklas Westerholm, CEO of PledPharma.