Circassia Pharmaceuticals PLC (LON:CIR) has received confirmation its Duaklir COPD treatment will be reviewed by the US Food and Drug Administration.
A new drug application was submitted in June.
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The FDA will also review a re-labelling of another drug, Turdorza, for heart conditions associated with COPD, also known as smoker’s cough.
Both reviews are expected to be completed by 31 March 2019.
Steve Harris, Circassia's chief executive, said: “We believe that based on its broad clinical database, Duaklir, if approved, has the potential to become an important new treatment option for COPD patients in the United States.
“In addition, the inclusion of clinical data in Tudorza's prescribing information demonstrating cardiovascular safety and reductions in COPD exacerbations, if approved, would provide physicians with unique new information."
Duaklir is being developed by UK pharma giant AstraZeneca PLC but will be marketed in the US by Circassia, where it has exclusive rights.
A further US$100mln is payable on Duaklir approval.
Turdorza was also developed by Astra and Circassia will acquire full rights in the US with a payment of up to US$80mln.