The Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for elmiron® (pentosan polysulfate) for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions.
The European Medicines Agencies (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product elmiron®, intended for the treatment of bladder pain syndrome (BPS) characterised by either glomerulations or Hunner’s lesions in the urine bladder mucosa. The clinical pattern is also known as Interstitial Cystitis (IC).
The final decision about the market authorisation is taken by the European Commission. In case of a positive decision elmiron® is going to be the first approved medicinal product in Europe for the treatment of bladder pain syndrome characterised by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition. “We welcome the CHMP recommendation for granting the marketing authorisation for elmiron® and appreciate this confirmation of our efforts making a medicinal product available to these sensitive patients with currently no approved therapy option in Europe”, says Dr. Guenter Auerbach, CEO of bene-Arzneimittel.
About Bladder Pain Syndrome (BPS)
The bladder pain syndrome characterized by either glomerulations or Hunner’s lesions is a severe chronic bladder disease that substantially reduces quality of life. For those affected by the condition, it means very frequent and painful urination, as well as severe pain in the lower abdomen. 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.
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.
About Pentosan Polysulfate (PPS)
In European guidelines, pentosan polysulfate (PPS) is specified as a standard drug for the treatment of bladder pain syndrome. Due to its structural similarity to glycosaminoglycans, PPS is able to rebuild the damaged GAG layer of the bladder, thus preventing harmful substances from penetrating into the underlying tissue layers. In addition, PPS also promotes the inhibition of the release of the tissue hormone histamine, thereby reducing the accompanying symptom of inflammation caused by the disease.
The bene group is worldwide the only manufacturer of the approved and authorized substance pentosan polysulfate.