Specialty pharmaceutical company, Alliance Pharma, has revealed that following discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM), the marketing authorisation application for Diclectin is now considered approvable.
Approval
Diclectin is a prescription treatment for nausea and vomiting in pregnancy and was in-licensed from Duchesnay (Canada) for the UK in 2015 and for a further nine European territories in 2016. It has a well-established efficacy and safety profile and was approved for use in the US in 2013.
“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,” said Peter Butterfield, Alliance Pharma’s chief executive officer. “For Alliance, Diclectin represents a sizeable mid-term opportunity and also allows us to further leverage our European footprint.”
“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,” added Éric Gervais, Duchesnay's executive vice-president. “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.”
The company is now awaiting formal marketing authorisation from the MHRA, which is expected in the coming weeks. It is anticipated that the UK launch will happen in the autumn of this year.
Once approval in the UK is obtained, the company expects to commence the filing of the necessary applications for regulatory approvals for further European territories in advance of launches later in 2019.