Alliance Pharma has had its UK Marketing Authorisation Application for Diclectin, a prescription product for treating nausea and vomiting during pregnancy, approved.
The Medicines and Healthcare Products Regulatory Agency (MHRA) also approved the brand name Xonvea, which will be used for marketing Diclectin in the UK.
Alliance anticipates Xonvea’s launch in autumn this year as the only medicine licensed in the UK for the treatment of nausea and vomiting of pregnancy.
Xonvea was in-licensed from Duchesnay of Canada for the UK in 2015 and for a further nine European countries in 2016, including Austria, France and Switzerland.
Nausea and vomiting of pregnancy is the most common medical condition in pregnancy affecting approximately 690,000 women in the UK each year according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists.
Research shows that up to 40% of pregnant women report symptoms of nausea and vomiting of pregnancy sufficiently severe to interfere with daily life whilst NHS data shows that at least 33,000 women with the condition are hospitalised each year.
Alliance estimates peak sales for Xonvea in the UK of approximately £10 million and across the other nine European countries a further £30 million approximately at peak sales.
The Group will incur both upfront costs ahead of the launches in the UK and EU markets and further incremental costs to support in-market growth in these countries.
Xonvea is the most studied medicine in pregnancy, with a proven efficacy and safety profile from use in more than 30 million women over more than 30 years.
Following marketing authorisation in the UK, Alliance is preparing to file the necessary applications for regulatory approvals in continental Europe.