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FDA knocks-back second Vernalis cough and cold treatment

US regulator delivers another complete response letter to the UK firm


Vernalis’ hopes of bringing either of its cough-cold drugs CCP-07 and CCP-08 to the US market in time for the 2017-2018 winter have been dashed.

Back in April the Food and Drug Administration (FDA) sent a complete response letter (CRL) for CCP-07 and the US regulator has now followed that up with another CRL rejecting CCP-08 that covers similar ground.

Ian Garland, chief executive officer of Vernalis, said: “Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08.

“The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely the FDA to resubmit both NDAs as quickly as possible.”

Vernalis - which has been working with privately owned, US-based Tris Pharma - is now hoping to regain some confidence by resubmitting its NDAs, but so far it has only said it will provide updates on this within the coming months.

The cough cold market is no stranger to the British biopharma group however, as it already has a medicine on the US market for that indication. Tuzistra (codeine polistirex and chlorpheniramine) was approved by the FDA back in April 2015.

The group also has two other approved products on the market, including Moxatag (amoxicillin extended release) indicated for the treatment of tonsillitis and pharyngitis in adults and paediatric patients, and frovatriptan for the acute treatment of migraines.

Article by
Gemma Jones

16th August 2017

From: Regulatory



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