Roche and partner Biogen Idec are discontinuing development of their late-stage rheumatoid arthritis treatment ocrelizumab, a couple of months after data was released pointing to serious infections that can cause death.
The decision is not surprising seeing as how the two firms suspended the RA prpgramme for the drug in March. That followed a recommendation of the independent data and safety monitoring board assessing the compound in four RA and two lupus trials; subsequently, the US Food and Drug Administration placed the RA studies on clinical hold.
This morning Roche issued a statmement saying that “following a detailed analysis of the efficacy and safety results from the RA programme, the companies concluded that the overall benefit to risk profile of ocrelizumab was not favourable in RA taking into account the currently available treatment options”. The drug is a follow-up to Roche/Biogen’s blockbuster MabThera/Rituxan (rituximab), which is also a part human/part mouse antibody.
Hal Barron, chief medical officer at the Swiss major said that “although this outcome is disappointing for patients, Roche remains committed to the development of treatments for RA”. Ocrelizumab is still being evaluated for relapsing-remitting multiple sclerosis and a Phase II study is on-going.
