Synergy wins U.S. approval for constipation drug (Jan 19)




(The Jan. 19 story corrects paragraph 9 to say Ironwood Pharma also sells Linzess in North America)

(Reuters) - The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation (CIC).

Synergy's once-daily tablet, Trulance, is the company's first to win regulatory clearance.

However, the safety and effectiveness of the drug have not been established in patients less than 18 years of age, the FDA said. (http://bit.ly/2k5wNlA)

The company's shares were marginally down at $6.40 in extended trading. The stock had gained about 28 percent in one month.

CIC, which affects 14 percent of the global population, is a type of gastrointestinal disorder where individuals have difficult and infrequent bowel movements. It is called idiopathic because the cause is unknown.

Trulance met the main goals of two late-stage studies in December on irritable bowel syndrome patients with constipation (IBS-C).

Synergy's Trulance, whose chemical name is plecanatide, is expected to generate peak sales of $348.8 million by 2021, according to Thomson Reuters Cortellis.

The drug is expected to compete against Ironwood Pharmaceuticals Inc's Linzess, which got approved in 2012 to treat IBS-C and CIC in the United States.

Linzess, which is sold by Allergan Plc and Ironwood in North America, AstraZeneca Plc in China, Hong Kong and Macau, Allergan in Europe and Astellas Pharma Inc in Japan, generated global sales of $464.7 million in the nine months ended Sept. 30.

(Reporting by Divya Grover, Dipika Jain and Komal Khettry in Bengaluru; Editing by Maju Samuel)

COMMENTS

More Related News

U.S. FDA approves Takeda
U.S. FDA approves Takeda's lung cancer drug as second-line treatment

(Reuters) - Japan's Takeda Pharmaceutical Co Ltd said on Friday that the U.S. Food and Drug Administration approved its lung cancer drug, almost three months after the company acquired the drug's developer, Ariad Pharmaceuticals Inc. The drug, Alunbrig, is approved as a second-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, who have progressed on or are intolerant to Pfizer's crizotinib, the standard initial treatment for the disease. Alunbrig was approved under the FDA's accelerated approval program, which allows for quicker approval of drugs that fill an unmet medical need. Takeda in mid-February completed its...

Beware of Bogus Cancer Treatments, FDA Says
Beware of Bogus Cancer Treatments, FDA Says

Americans should be wary of products claiming to treat or cure cancer, as a number of products are falsely making these claims, according to the Food and Drug Administration. Today (April 25), the FDA sent warning letters to 14 U.S. companies saying that the businesses are breaking the law by making unproven claims about their products. "Consumers should not use these or similar unproven products, because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment," Douglas Stearn, director of the Office of Enforcement and Import Operations at the FDA, said in a statement.

Leave a Comment

Your email address will not be published. Required fields are marked with *

Cancel reply

Comments

Top News: Europe

facebook
Hit "Like"
Don't miss any important news
Thanks, you don't need to show me this anymore.