Shire earns EMA nod for constipation drug

Shire has seen approval from the European Medicines Agency to extend the licence of its constipation drug Resolor for men with chronic constipation.

The treatment has been given the go-ahead for men for whom laxatives have failed to work. Resolor (prucalopride) is approved for use in women in Europe, and has been since 2009, so the new variation extends the use of this treatment to males.

The company was able to prove the treatment is effective in men in a clinical trial in 370 men, which found that a statistically significantly higher percentage of men who took Resolor (37.9%) experienced normal bowel function after 12 weeks, compared with 17.7% of men in the placebo treatment group.

And in trials of men and women a quarter of people had normal bowel function after twelve weeks of treatment – more than twice that in the placebo group.

“The extension of the Resolor label to include use in men is an important development in the treatment of chronic constipation,” says Roger Adsett, head of the gastrointestinal and internal medicines business unit at Shire. “We are pleased to now be able to offer the benefits of Resolor to even more chronic constipation patients in need of treatment options.”

Chronic constipation is estimated to affect up to 14% of the population, and Professor Yan Yiannakou who is the principal trial investigator of the Resolor male study, and professor of neurogastroenterology, notes it “can cause severe symptoms, affect quality of life and lead to significant healthcare resource utilisation.”

He adds: “We know that laxatives are often inadequate or unsatisfactory for patients with chronic constipation. The availability of prucalopride for men now offers an effective treatment option when laxatives fail to provide symptom relief.”

Also this week in separate news, NICE has recommended Boehringer Ingelheim’s lung cancer drug Vargatef (nintedanib) in final draft guidance. Vargatef is recommended as an option for treating locally advanced, metastatic or locally recurrent non-small-cell lung cancer that has progressed after first-line chemotherapy.

Lilian Anekwe

http://www.pharmafile.com/news/396572/shire-earns-ema-nod-constipation-drug

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