Vectura awaits more details from FDA over Advair

Drug delivery specialist Vectura has noted comments on Thursday morning by Hikma, its partner on the development of a generic version of the Advair Diskus asthma treatment.

Following the 'complete response letter' issued by the US Food and Drug Administration in May, the pair confirmed that discussions with the regulator are ongoing and that a number of the questions raised have been resolved.

Hikma and Vectura have "had constructive discussions with the FDA and have been able to clarify and resolve a number of the questions raised.

"The discussions with the FDA have confirmed the initial assessment that there are no material issues regarding the substitutability of the proposed device."

Discussions remain ongoing and the partners will provide more detailed updates when appropriate.

Analysts at Shore Capital said they currently assume re-filing of the application in the first half of 2018 and forecast risk-adjusted (50%) sales from 2019.

Forecasts from broker N+1Singer assume these outstanding items can be addressed by year-end, "which could result in approval in H2 2018".