Date: 2015-01-30
Type of information: Granting of a Market Authorisation in the EU
Product name: Amitiza®
Compound: lubiprostone
Therapeutic area: Digestive diseases
Action mechanism: prostaglandin. Amitiza® (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated in the United States (U.S.) for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. Amitiza® is also indicated in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan , Amitiza® (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the U.K. , Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In Switzerland, Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of Amitiza® for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.
Company: Sucampo Pharmaceuticals (USA - MD)
Disease: chronic idiopathic constipation
Latest news: * On January 30, 2015, Sucampo Pharmaceuticals announced the successful completion of the European Mutual Recognition Procedure (MRP) for Amitiza® (lubiprostone) for the treatment of chronic idiopathic constipation in select European countries, resulting in a recommendation for marketing authorization. Based on the approval in the United Kingdom , a mutual recognition application was filed in Austria , Belgium , Germany , Italy , Ireland , Luxembourg , Netherlands and Spain . Following the positive MRP outcome, each member state is expected to issue a national marketing authorization.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2006-01-31
UE authorization:
Favourable opinion UE: 2015-01-30
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
