MHRA approves UK marketing authorisation application for Diclectin

Specialty pharmaceutical company, Alliance Pharma, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK marketing authorisation application for Diclectin.

Diclectin is a prescription-based medicine for the treatment of nausea and vomiting during pregnancy. It will be marketed under the brand name Xonvea — which has also been approved by the MHRA — in the UK and its launch is expected in the autumn time this year.

“Confirmation of the marketing authorisation for Xonvea is another positive step for Alliance and I’m delighted that we are able to launch the product later this year,” stated Peter Butterfield, Alliance Pharma's chief executive officer. “There are currently no licensed treatments for nausea and vomiting of pregnancy in the UK so this is excellent news for patients and clinicians as it fulfils a significant unmet medical need.”

Xonvea was in-licensed from Duchesnay of Canada for the UK in 2015 and for a further nine European countries— Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland — in 2016.

“Pregnant women across the UK will now have access to an effective treatment for morning sickness with a proven safety profile,” added Éric Gervais, Duchesnay’s executive vice-president. “Alliance Pharma’s focus and drive will ensure that this needed medication, used to date by more than 30 million women worldwide, will provide pregnant women in the UK with a licensed treatment option. Alliance is also preparing applications to ensure the product’s availability in continental Europe.”