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Linaclotide, the first drug to treat IBS-C, was approved in China

【摘要】:
AstraZenecaannouncedon15January,2019thattheNationalMedicalProductsAdministration(NMPA)hasofficiallyapprovedthemarketingapplicationforLinzess(linaclotide),thefirst-inclassguanylatecyclaseC(GC-C)recepto

AstraZeneca announced on 15 January, 2019 that the National Medical Products Administration (NMPA) has officially approved the marketing application for Linzess (linaclotide), the first-in class guanylate cyclase C (GC-C) receptor agonist as the prescription drug for adults with irritable bowel syndrome with constipation (IBS-C) in China.

Linzess (linaclotide) was the first guanylate cyclase-C agonist approved by FDA in August 2012, for the treatment of IBS-C and chronic idiopathic constipation. In addition, FDA approved the 72-μg linaclotide for adults with chronic idiopathic constipation (CIC) in February 2017 . Linzess was also approved as the first prescription drug for the treatment of IBS-C in Japan in December 2016 and has been on the Japanese market since March 2017.

Up to now, Linzess (linaclodite) has been approved in more than 30 countries as the global leading prescription drug for the treatment of IBS-C.

 

Irritable Bowel Syndrome with Constipation (IBS-C)

Irritable bowel syndrome (IBS) is a common clinical functional bowel disease. The clinical symptoms of Irritable bowel syndrome with constipation (IBS-C), a subtype of IBS, are mainly characterized by recurrent constipation accompanied by defecation-related abdominal pain, bloating, and discomfort. Frequent occurrence of IBS will affect the patient’s quality of life.

In China, the prevalence of IBS is as high as 6.5%, of which 15% is IBS-C. it is estimated that the number of people with IBS-C in China is approximately 14 million. Before Linzess (linaclodite) was approved in China, the treatment of IBS-C patients was mainly based on a choice of symptoms such as antispasmodics and osmotic laxatives. Within China, there has been a lack of effective target drugs; the approval of Linzess (linaclodite) will therefore offer Chinese doctors and a large number of patients a host of brand new and effective treatment options, thus filling an important gap in the field of adult IBS-C treatment in China.

 

Chronic Idiopathic Constipation (CIC)

Chronic functional constipation attacks a wide range of people and can be caused by multiple factors. The main symptoms include difficulty passing stools, discomfort with bowel movement and prolonged duration of defecation. Based on its causes, Chronic Idiopathic Constipation (CIC) can be divided into primary (idiopathic) constipation and secondary constipation. Because the cause for idiopathic constipation is unclear, and treatment also difficult, it therefore is also called either “refractory” or “primary” constipation. CIC and IBS-C are similar, both of which have considerable symptom overlap and are mainly identified from abdominal symptoms. The abdominal pain from IBS-C may not be relieved by defecation.

According to statistics, IBS has about 11% of global incidence and CIC has about 14%; both of them have complex pathogenesis. Though IBS and CIC are not generally considered to be related to certain severe diseases or to those with higher mortality, the patients’ life quality is seriously affected.

 

Abstract of the Drug

Drug Name: Linaclotide

Brand Name: Linzess®

Linaclotide, a guanylate cyclase C (GCC) agonist with a structure of 14-amino acid polypeptide, can bind and locally activate GC-C receptors in intestinal epithelial cells. The activation of GC-C increases intracellular and extracellular cyclic guanosine monophosphate (cGMP) concentration levels, and the increased levels of intracellular cGMP stimulate the chloride and bicarbonate ions secretion into the intestinal lumen, increasing the intestinal secretions and accelerating the passages. The animal models have shown that linaclotide relieves small intestine pain, which is considered to be caused by an increase in extracellular cGMP that reduces the activity of intestinal pain-sensing nerves, thus inducing the relief of visceral pain.

 

Patent Information

Linaclotide has 10 related US patents registered in the Orange Book, and has 7 patent families in China. All of these US patents have been authorized, and 2 patents in China are in the stage of substantive examination.

Publication Number

Patent Name

Application Date

Legal Status

US7304036

Methods and compositions for the treatment of gastrointestinal disorders

2004-03-09

Authorized

US7371727

Methods and compositions for the treatment of gastrointestinal disorders

2004-07-27

Authorized

US7704947

Methods and compositions for the treatment of gastrointestinal disorders

2007-10-31

Authorized

US7745409

Methods and compositions for the treatment of gastrointestinal disorders

2007-12-03

Authorized

US8080526

Methods and compositions for the treatment of gastrointestinal disorders

2010-04-05

Authorized

US8110553

Methods and compositions for the treatment of gastrointestinal disorders

2010-05-27

Authorized

CN101787073B

Methods and compositions for the treatment of gastrointestinal disorders.

2004-01-28

Authorized

CN100589839C

Polypeptide and pharmaceutical compositions comprising a polypeptide.

2004-01-28

Authorized

US8748573

Formulations comprising linaclotide

2010-08-05

Authorized

US8802628

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

2009-08-14

Authorized

CN102186490B

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

2009-08-14

Authorized

CN109010254A

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

2009-08-14

Substantive Examination

CN105168114A

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

2009-08-14

Substantive Examination

US8933030

Treatments for gastrointestinal disorders

2011-02-17

Authorized

CN102869677B

Treatments for gastrointestinal disorders

2011-02-17

Authorized

US9708371

Treatments for gastrointestinal disorders

2012-08-17

Authorized

CN104053449B

Treatments for gastrointestinal diseases.

2012-08-17

Authorized

 

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