New NHS drug for “morning sickness”, approved July 2018
Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK Marketing Authorisation Application for Diclectin®, a prescription product for the treatment of nausea and vomiting of pregnancy.
Alliance also confirms that the MHRA has approved the brand name Xonvea®, which will be used for marketing Diclectin in the UK. As previously indicated, 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 Inc. of Canada (“Duchesnay”) for the UK in 2015 and for a further nine European countries in 2016 – Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland 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.
The Group estimates peak sales for Xonvea in the UK of approximately £10m and across the other nine European countries a further £30m 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. Alliance expects to generate meaningful sales of Xonvea from H2 2019.
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.
Related : read What you don’t know about a leading morning-sickness drug, by Anne Kingston Oct 23, 2015 on macleans.
Woman, whose daughter died at 14 months, sues GSK over drug she took while pregnant
Nov 27, 2015 – CALGARY – The makers of an anti-nausea drug prescribed to pregnant women for morning sickness are being sued for $11-million by an Alberta woman whose daughter died 10 years ago.
In 2012, the US Department of Justice announced that GlaxoSmithKline, maker of Zofran, would pay more than $1 billion to settle claims that it illegally marketed Zofran and other medications for off-label, unapproved uses. Specifically, GlaxoSmithKline allegedly “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” Although doctors are free to prescribe Zofran for off-label use, it is illegal for a drug company to market its medications for unapproved uses.
Sources and more information
Woman, whose daughter died at 14 months, sues GSK over drug she took while pregnant, cnews, Nov 27, 2015.
DRUG JUSTICE – PHARMACEUTICAL COMPANIES SHOULD PAY FOR THEIR MISTAKES
” We are campaigning to have Grunenthal and Sanofi face their obligations and to stop hiding behind the protection of European legislation, face their responsibility and their guilt, and pay adequate compensation to the thousands of victims affected by their drugs.
The drug thalidomide – marketed for pregnant women suffering with morning sickness – was invented and sold by a German pharmaceutical company called Grunenthal between 1957 and 1961. Thalidomide killed most babies in the womb and those who survived are severely injured and disabled. The drug Epilim (Sodium Valproate) was marketed in 1973 as a drug for Epilepsy and to date has affected approx. 20,000 babies in a similar disastrous way.
Grunenthal has never compensated any British thalidomider. We ask that Grunenthal face their responsibility and give financial compensation to thalidomide damaged people in the UK. Grunenthal’s CEO must sit down with the thalidomide representatives and discuss financial compensation not just for the suffering and pain of living with thalidomide but also for the ongoing extra costs of living with the pain caused by thalidomide “.
Jill Escher, from Prenatal Exposures Never Die, the blog about epigenetics, autism, and the multigenerational tragedy of prenatal pharmaceutical use, wrote to the FDA on April 11. 2013.
“ I am writing to urgently request that the FDA take immediate steps to suspend approval for the prenatal drug Diclegis pending appropriate safety testing for impacts to fetal germ cells, the precursor cells to the baby’s egg or sperm. In addition, I urge the FDA to take immediate steps to issue warnings regarding potential germline impact of all prenatally administered drugs… ”
A new pregnancy drug, the Diclegis® pill manufactured by Duchesnay Inc. Canada, will enter pharmacies this June 2013. This week (see tweet), in its news release, the FDA stated: ” The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting “.
The “Morning Sickness Drug“, was called Bendectin between 1978 and 1983, and had over 300 lawsuits filed against the Merrell Dow pharmaceutical company, claiming damages for babies with deformities born to mothers who took the drug. The wide range of birth defects attributed to it were: limb and other musculoskeletal deformities; facial and brain damage; defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems; blood disorders and cancer.
With many thanks to Judith Kavanaugh for warning me about this unbelievable but true news !!!