Faron Pharmaceuticals Ltd (LON:FARN) has been granted investigational new drug (IND) status for its flagship drug, Traumakine, by the US regulator.
The Food & Drug Administration has already said Faron can proceed directly to a biologics licence application (BLA) if the results from a European Phase III clinical study are positive.
READ: Faron Pharmaceuticals receives clinical trial green light in second indication for lead drug
The firm is also planning to conduct a small open-label study in the US for “pharmacological purposes” and the IND will allow the opening of clinical activities in the States.
"We are very pleased to receive this IND approval from the FDA which will allow us to further advance our Traumakine plans in the US,” said chief executive, Dr. Markku Jalkanen.
Rolling dossier
Faron said it wants to build up a rolling dossier for the FDA, which could speed up the final acceptance of the BLA.
The drug, which is used to treat acute respiratory distress (ARDS), recently completed recruitment for a Phase III trial in Europe, with initial data expected later in the first half.
This, with the legwork already put in with the American watchdog, may help smooth the road to regulatory acceptance.
“We remain hopeful that we can expedite Traumakine's route to market addressing this significant unmet medical need in terms of reducing mortality and providing savings for healthcare systems," said CEO Jalkanen.
The shares nudged 2% higher in morning trade to 858p, valuing the business at £250mln.
Traumakine is also being trialled on patients with ruptured abdominal aorta aneurysms.
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