UCB is touting the "greater convenience" of Cimzia subcutaneous injection for Crohn's disease compared to Johnson & Johnson's intravenous injection Remicade (infliximab).

The firm announced the BLA submission March 2. If granted a requested six-month priority review, Cimzia (certolizumab pegol, CDP870) could be approved by early September.

In addition to being the first subcutaneous injection for Crohn's disease, Cimzia would be the "first and only PEGylated Fab fragment of a humanized anti-[tumor necrosis factor] alpha antibody," UCB said.

J&J's TNF inhibitor Remicade, which debuted in 1998, is the only biologic currently approved for Crohn's disease. AstraZeneca's oral synthetic corticosteroid Entocort EC (budesonide) subsequently received NDA approval in 2001.

"Subcutaneous administration is a welcomed attribute for patients and can offer greater convenience," Cimzia lead investigator William Sandborn (Mayo Clinic) said.

The Cimzia BLA is supported by UCB's pivotal PRECiSE 1 and 2 trials, with primary endpoints of induced clinical response, maintenance of response and remission.

In PRECiSE 2, a clinical response was achieved by 64.1% of Cimzia patients within six weeks; "significantly more" patients maintained an overall clinical response at 26 weeks versus placebo (62.8% vs. 36.2%), according to UCB. The clinical remission rate also was significantly higher for Cimzia compared to placebo (47.9% versus 28.6%).

UCB also is pursuing a potential Cimzia claim for moderate to severe rheumatoid arthritis, currently in Phase III.

FDA could also see Crohn's disease BLA filings during 2006 for Abbott's Humira (adalimumab) and Schering AG's Leukine (sargramostim), according to FDC Reports' NDAPipeline.

Crohn's treatments in Phase III also include Biogen Idec's Tysabri (natalizumab). While dosing was suspended a year ago due to safety concerns, issues related to the biologic's potential return to market for multiple sclerosis will be considered by FDA's Peripheral & Central Nervous System Drugs Advisory Committee March 7-8 (¹ Also see "Tysabri Relatively Safe For Short-Term Use, NEJM Concludes" - Pink Sheet, 1 March, 2006.).

[Editors' note: To watch a webcast or order a video/DVD of this meeting, please visit FDAAdvisoryCommittee.com.]

- Jon Dobson

UCB Cimzia BLA Submission Could Provide First Subcutaneous Injection For Crohn’s

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