Azanta A/S files Marketing Authorisation Application for Angusta®
Hellerup, Denmark, February 25, 2016.
Azanta A/S announces that a marketing authorisation application for Angusta® has been filed in the Nordic countries. Angusta® is Azanta’s proprietary 25 micrograms misoprostol tablet for oral use for induction of labour.
Hanne Damgaard Jensen, CEO of Azanta A/S says: “The filing for regulatory approval in the Nordics is a step towards our first wave launch of Angusta®.” We are very happy to have accomplished this milestone. There is a worldwide-unmet medical need for a registered oral misoprostol product at the right strength for labour induction. It is important for the women giving birth, the unborn children, treating physicians, midwives and the healthcare system in general, that a potent medicinal product such as misoprostol is provided as an approved medicine at the recommended dose.”
Richard H. Poulsen, General Manager of Azanta Danmark says: “I am very happy that we are now one step closer to offering a registered oral misoprostol product (Angusta®) for labour induction in the Nordic countries. For many years obstetricians have claimed the need for a 25 micrograms misoprostol tablet for oral use. In 2011 the World Health Organisation (WHO) issued a guideline recommending misoprostol at 25 micrograms for oral use. The recommendation was based on very comprehensive scientific reviews of published clinical data. Oral misoprostol is also recommended in treatment guidelines from DSOG (Danish Society of Obstetrics and Gynaecology), NGF (Norwegian Society for Gynecology and Obstetrics) and SFOG (The Swedish Society of Obstetrics and Gynecology)”.
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About Angusta® and labour induction
Angusta® is Azanta’s proprietary 25 micrograms misoprostol tablet for oral use for induction of labour. The oral application is made possible using Azanta’s proprietary formulation. Initially, Azanta files for regulatory approval in Europe through the decentralized procedure. The first wave of registrations is in the Nordic countries. There can be no assurance that Angusta® will receive regulatory approval. Azanta currently provides Angusta® on a “named patient/compassionate use basis” in Denmark, Norway and Finland.
Induction of labour is performed all over the world. In the Western world, labour induction is carried out in 20-25% of pregnant women. Labour induction is indicated in cases where continuation of pregnancy is hazardous to the mother and/or her unborn child.
Where induction of labour is indicated, the WHO recommends the application of 25 micrograms misoprostol orally every 2nd hour. Other guidelines recommend 50 micrograms orally every 4th hour or misoprostol 25 micrograms vaginally every 6th hour.
About Azanta A/S
Azanta A/S is a privately owned specialty pharma company primarily operating within oncology, women´s health and addiction medicine. Azanta seeks to be an international market leader within certain specialty pharma product categories, employing innovative repositioning and drug formulation strategies. Azanta A/S currently markets (or makes available under special authorisation) a portfolio of specialty pharmaceutical products, including Nimoral™, a hypoxic radiosensitizer for the treatment of head and neck cancer patients undergoing primary radiotherapy and Angusta® for labour induction.
For further information, please visit www.azanta.com.
Hanne Damgaard Jensen – CEO
Tel: + 45 – 70 25 95 45
Fax: + 45 – 70 25 95 46