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Hospital Healthcare Europe

bene-Arzneimittel receives orphan drug status for pentosan polysulphate


18 December, 2015  

In European and US medical guidelines, pentosan polysulphate is established as a standard drug for the treatment of the severe chronic bladder disease interstitial cystitis (IC).

The drug has been awarded the status of an orphan drug from the European Medicines Agency, EMA, for the indication of IC.

Interstitial cystitis (IC) is a rare or so-called orphan disease. The drug substance PPS has been officially registered as an orphan drug for this indication by the European Medicines Agency, EMA. “Receiving orphan drug status for pentosan polysulphate in the European Union is a great success for bene,” says CEO Dr Guenter Auerbach. “To be able to offer patients with rare but serious conditions innovative medications in the area of urology is an important milestone for the future of our company.

About IC
IC is a severe chronic bladder disease that substantially reduces quality of life. Affecting less than two patients per 10,000 people on average and being associated with a large degree of suffering, the condition has been officially recognised as an orphan disease. For those affected by the condition, it means very frequent and painful urination, as well as severe pain in the lower abdomen.

The causes of this chronic disease include damage to the bladder lining, affecting the glycosaminoglycan (GAG) layer in particular. As a result, the protective effect of this layer is reduced, and toxic constituents of urine are able to penetrate into underlying tissue layers and cause tissue irritation or inflammation.