Cosmo Pharmaceuticals N.V. announced that Ferring, cosmo's partner for Cortiment® MMX® (budesonide), submitted the NDA for Japan on June 23, 2022, and the application has been accepted by PMDA (Pharmaceuticals and Medical Devices Agency). The review is expected to last approximately a year. Cortiment®is a once-daily oral tablet formulation which delivers budesonide directly to the lumen of the colon.

Budesonide is a corticosteroid that has mainly topical anti-inflammatory activity. It is prescription-only and is used to help get active, mild to moderate Ulcerative Colitis under control (induce remission) and may help relieve the symptoms of ulcerative colitis. Cortiment has been developed by Cosmo.

In 2015, Cosmo had signed a licensing agreement with Ferring Pharmaceuticals, granting Ferring the rights to Cortiment® MMX® for Japan. Ferring is the licensee in the EU and the rest of the world. In the United States, where the product is available as Uceris, the licensee is Bausch.

In Japan it is believed that as many as 180,000 people suffer from Ulcerative Colitis, a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks.

In phase III studies, 2.4 to 3.9 times more patients achieved clinical remission and mucosal healing with Cortiment® compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I study and CORE II study respectively).