UCB has been “eagerly awaiting” FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. Now, the wait is over.
The med is the first psoriasis treatment that works by selectively inhibiting interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines that play a hand in the inflammatory process, according to a UCB release. The approval covers the treatment of moderate-to-severe plaque psoriasis in adults who qualify for systemic therapy or phototherapy.
In phase 3 trials, Bimzelx proved its worth against placebo and the popular psoriasis drugs AbbVie’s Humira and Johnson & Johnson’s Stelara. Across all studies, 85% to 91% of Bimzelx-treated patients achieved clear or almost clear skin by week 16, as measured by the Psoriasis Area & Severity Index (PASI) or investigator assessment.
In addition, across the studies, 59% to 68% of patients experienced complete skin clearance (or PASI 100) by week 16, according to the company.
The approval comes after a few bumps in the regulatory road for the drug. The FDA initially delayed its approval decision in October 2021 because COVID-related travel restrictions prevented the agency from conducting an inspection at UCB’s Belgian manufacturing facility.
After the FDA finally visited the site last year, a complete response letter followed in May 2022. The FDA inspected the plant again this April after accepting UCB’s resubmitted application and closed out the inspection last month.
The psoriasis nod is just the beginning for Bimzelx. The company will now “move forward rapidly” to file for additional indications, executive vice president of immunology solutions and head of UCB’s U.S. business, Emmanuel Caeymaex, said in a statement.
With its future filings, the company plans to target diseases that the drug is already approved to treat overseas, including generalized pustular psoriasis, non-radiographic axial spondyloarthritis and psoriatic arthritis.
Thanks to the delay, UCB had time to collect the necessary data in the other indications, meaning future filings will be “accelerated,” CEO Jean-Christophe Tellier said in an interview. The CEO said Bimzelx boasts a “best-in-disease” profile in both psoriasis and psoriatic arthritis and offers a “tremendous value proposition."
UCB expects the drug's global peak sales to reach at least 4 billion euros. Bimzelx has launched in Europe, Japan, the U.K. and other countries and generated 52 million euros in the first half of 2023. The med will be available in the U.S. in approximately one month, the company said.
For now, the company is celebrating a double whammy with another brand-new drug approval. UCB's Zilbrysq is now cleared to treat generalized myasthenia gravis in certain patients.