AbbVie’s JAK inhibitor Rinvoq has been approved by the European Commission for the treatment of moderate-to-severe rheumatoid arthritis.
It will now be available for adult rheumatoid arthritis (RA) patients across Europe, who have not responded to or are intolerant to at least one disease-modifying anti-rheumatic drug.
AbbVie needs a next-generation immunology drug to counteract the offset from declining sales of its ageing immunology blockbuster Humira (adalimumab).
The pharma company has been pushing Rinvoq (upadacitinib) into the RA market, while its Boehringer Ingelheim-partnered drug Skyrizi (risankizumab) has been making headway in psoriasis.
The approval of Rinvoq in RA was supported by data from the phase 3 SELECT programme, which evaluated almost 4,400 patients with moderate-to-severe active RA across five studies.
Across these phase 3 studies, Rinvoq met all its primary and secondary endpoints. Low disease activity and clinical remission rates were consistent across the patient populations.
“We are proud to offer this once-daily tablet as a new treatment option for patients with moderate-to-severe active rheumatoid arthritis,” said Michael Severino, vice chairman and president of AbbVie.
“As a company that has been dedicated to discovering and delivering transformative therapies for people living with rheumatic diseases for nearly two decades, Rinvoq expands our portfolio of treatment options for people living with this disease in Europe,” he added.
The approval in Europe will be come as some much-needed good news for AbbVie, after US cost-effectiveness watchdog ICER recently released a report that concluded Rinvoq has only a ‘marginal clinical benefit’ over Humira, but with a more costly price tag.
In a head-to-head trial of the two drugs, Rinvoq demonstrated statistically significant higher rates of disease remission and improvement in other outcomes when compared to Humira – however, ICER said the benefit was only ‘modest’.
ICER also presented concerns over the long-term impact of next-generations drug treatments for RA, although many have criticised its methods of determining benefit.
This includes a number of patient organisations who argue that drugs like Rinvoq and Pfizer’s JAK inhibitor Xeljanz (tofacitinib) have created real improvements for people living with the condition.