Production & Manufacturing
Process & Production

UK's MHRA, CHM adopt positive opinion on approval of Alliance Pharma's Diclectin

Published 08 June 2018

Alliance Pharma said that the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have adopted a positive opinion for the approval of Diclectin.

Alliance awaits issue of the formal Marketing Authorisation from the MHRA in the coming weeks, with UK launch anticipated to be in the autumn of this year.

Diclectin, a prescription treatment for nausea and vomiting of pregnancy, was in-licensed from Duchesnay Inc. of Canada ("Duchesnay") for the UK in 2015 and for a further nine European territories in 2016.

Diclectin has a well-established efficacy and safety profile and is regarded as the standard of care for nausea and vomiting of pregnancy in Canada, where it has been used for over 40 years and has been prescribed for more than 30 million women.

In 2013, Diclectin ("Diclegis") was approved in the United States with the highest possible safety rating for drugs used during pregnancy, FDA Category A, and has since been approved in Israel, South Korea and Singapore. 

Following the approval of Diclectin in the UK, Alliance expects to commence the filing of the necessary applications for regulatory approvals for further European territories in advance of launches later in 2019.

Alliance Pharma CEO Peter Butterfield said: "We are delighted by this news and look forward to launching Diclectin later this year. There are currently no licensed treatments for nausea and vomiting of pregnancy in the UK, highlighting a clear unmet need for patients and clinicians.

“For Alliance, Diclectin represents a sizeable mid-term opportunity and also allows us to further leverage our European footprint."

Alliance Pharma executive vice-president Éric Gervais, Duchesnay said: "Nausea and vomiting of pregnancy is a common medical condition that can affect up to 80% of all pregnant women. It can be debilitating and can worsen if left untreated.

“We continue to support Alliance in their efforts to provide a licensed treatment, which has a proven safety and efficacy profile, for women in the UK suffering from morning sickness."

Source: Company Press Release.