LONDON (ShareCast) - (ShareCast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals announced on Monday that the FDA had proposed that the company could proceed directly to Biologics License Application (BLA) submission, pending positive results from the two ongoing Phase III trials with the company's wholly-owned product, 'Traumakine', for the treatment of acute respiratory distress syndrome (ARDS).
The AIM-traded firm said that in the letter received on 1 September, the FDA proposed that - subject to the regulator being satisfied with data from the trials - the BLA application for Traumakine could be filed purely with data obtained from the ongoing trials outside of the US.

In the event of positive outcomes of the ongoing trials, Faron said that FDA feedback was therefore expected to shorten the time for approval of Traumakine in the US.

"We welcome the news that the FDA have proposed that we proceed directly to BLA submission for the US development of Traumakine," said CEO Dr Markku Jalkanen.

"This important feedback potentially speeds up the regulatory approval process in the US and brings us one step closer to delivering Traumakine to patients in the world's largest pharmaceutical market."

Dr Jalkanen said there was currently no approved pharmaceutical treatment for ARDS, and claimed Traumakine had the potential to address a "significant unmet medical need" in terms of mortality and savings for society.

"We now eagerly await the outcome of our ongoing Phase III trials and continue to build our presence in the US."

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