Shots:

• The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks.- SC- q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids- immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies
• Induction study results: Clinical response achievement (62% vs 31%); achievement of normal stool frequency and had no bleeding. Maintenance study results: sustained effect (57.4% & 48.3% vs 35.4%) as measured by double partial Mayo remission
• Stelara is a biologic targeting IL-12 and IL -23- approved to treat mod. to sev. plaque psoriasis in the EU. This marketing authorization follows EMA’s CHMP positive opinion received on July 25- 2019

Click here to­ read full press release/ article

Ref: Janssen | Image: Janssen