Johnson & Johnson (J&J) has received recommendations from the European Medicines Agency’s human medicines committee for three separate drugs in ulcerative colitis (UC), Crohn’s disease (CD) and multiple myeloma (MM).
Tremfya (guselkumab) has been recommended to treat moderately to severely active UC, a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract, in adults who have had an inadequate response, lost response or been intolerant to either conventional therapy or a biologic treatment.
The Committee for Medicinal Products for Human Use (CHMP) has also recommended J&J’s Stelara (ustekinumab) to treat paediatric patients weighing at least 40kg with moderately to severely active CD, another form of IBD, as well as its Darzalex (daratumumab) subcutaneous (SC)-based regimen for adults with newly diagnosed MM regardless of transplant eligibility.
The CHMP’s decision on Tremfya was supported by positive results from the phase 3 QUASAR programme, with the drug achieving the primary endpoint of clinical remission in the induction and maintenance studies and also demonstrating statistically significant and clinically meaningful improvements in symptoms compared to placebo.
Mark Graham, senior director, therapeutic area lead, immunology, J&J Innovative Medicine EMEA, described the committee’s decision on Tremfya as “a step towards being able to offer an additional treatment option for patients, ultimately enhancing their health outcomes and quality of life”.
The recommendation for Stelara, which also applies to patients who have had an inadequate response to, or been intolerant to either conventional or biologic therapy, was based on data from the late-stage UNITI-Jr trial, in which 52.1% of paediatric patients achieved clinical remission after eight weeks, with clinical response observed as early as week three. Results from the REALITI real-world evidence study also supported the committee’s decision.
Data from the phase 3 CEPHEUS study supported the CHMP’s positive opinion of Darzalex SC in combination with bortezomib, lenalidomide and dexamethasone (VRd), with the regimen demonstrating improved progression free survival in the frontline setting.
Edmond Chan, EMEA therapeutic area lead haematology, J&J Innovative Medicine, said: “It is increasingly evident that to continue optimising outcomes in MM, we must intervene early with the most effective therapies first.
“[This] positive recommendation, based on the CEPHEUS study, brings us closer to offering [Darzalex-VRd] as a treatment option for patients with newly diagnosed MM, regardless of transplant eligibility.”
The European Commission will now review the CHMP’s recommendations as it makes decisions on the three drugs in these indications.