Cosmo Pharmaceuticals N.V.
/ Key word(s): Regulatory Approval
Dublin, Ireland – 20 October 2022. Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) announces that the FDA has granted the orphan-drug designation request of rifamycin for treatment of pouchitis.
Patients with ulcerative colitis (UC) may require removal of their colon and rectum (proctocolectomy), and the surgical creation of an ileal pouch to aid stool retention (ileal pouch-anal anastomosis or IPAA). Pouchitis is a nonspecific inflammatory condition and the most common complication of an IPAA, with a reported incidence rate between 23% and 59% in patients with UC.
Patients with pouchitis can present with a wide range of clinical presentations, including increased stool frequency, urgency, tenesmus, incontinence, nocturnal seepage, abdominal cramping, and abdominal discomfort. Although bloody bowel movements are uncommon in typical pouchitis, patients can have iron-deficient anaemia. Patients with severe pouchitis occasionally present with fever, dehydration, and malnutrition, which may require hospitalization.
Patients with pouchitis are known to respond to off-label antibiotic therapy, although there is not yet an approved antibiotic product. Cosmo has conceived and developed a novel formulation to deliver Rifamycin SV, an antibiotic belonging to the Ansamycin family, to treat pouchitis. The granting of the Orphan Drug Designation (ODD) by the FDA is an essential step to streamline and accelerate the development of a much-needed treatment.
Alessandro Della Chà, CEO of Cosmo, said: “The grant of the ODD for Rifamycin from the FDA to treat pouchitis is another major advancement of our GI pipeline of innovative products. We will now swiftly pursue the clinical development of this new candidate”.
About Cosmo Pharmaceuticals
End of Media Release
|Company:||Cosmo Pharmaceuticals N.V.|
|Riverside 2, Sir John Rogerson’s|
|Dublin 2 Dublin|
|Phone:||+ 353 1 817 0370|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1467581|
|End of News||EQS News Service|
1467581 20.10.2022 GMT/BST