LONDON (Alliance News) - 4d pharma PLC said Thursday that it has been granted orphan drug designation for its Rosburix drug by the US Food and Drug Administration.
Rosburix is a treatment for ulcerative colitis in paediatric patients and is the second 4d pharma biotherapeutic to receive orphan designation, having received orphan designation from the FDA for the treatment of paediatric Crohns with Thetanix in September 2013.
PUC is an inflammation, or painful swelling of the lining of the large intestine or colon which can lead to sores and ulcers which can bleed, produce pus and cause pain. Although some patients with PUC do show periods of remission, PUC is a long term condition, requiring management throughout a patients' life.
Regulators grant orphan designation to treatments under examination that are intended for contending with rare diseases. For the US Food and Drug Administration, the status applies to treatments for disorders and diseases affecting fewer than 200,000 people in the country.
4d shares were trading 3.93% higher at 278.00 pence per share Thursday morning.
By Alice Attwood; aliceattwood@alliancenews.com; @AliceAtAlliance
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