Tags : Rheumatoid Arthritis

Regulatory

Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis

Shots: The approval is based on two clinical trials (P-III FINCH and P-II DARWIN) programs assessing Jyseleca in 3,500+ patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with SOC including biologic DMARDs. Gilead and Eisai will jointly commercialize Jyseleca across Japan […]Read More

Pharma Regulatory

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion

Shots: The CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage […]Read More

Biotech

Cumberland Pharmaceuticals’ RediTrex (methotrexate) Injection Receives the US FDA’s Approval

Shots: The approval of RediTrex is done post no. of communications with the FDA and several amendments to the NDA submitted to the FDA in late 2018 Cumberland to launch two injectable methotrexate product lines within the US targeted to treat active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis RediTrex (methotrexate) Injection is targeted […]Read More

Biosimilars

Pfizer’s Abrilada (biosimilar, adalimumab) Receives the US FDA’s Approval for

Shots: The US FDA approval is based on the clinical study assessing Abrilada (adalimumab-afzb) vs reference product, AbbVie’s Humira in 597 biologic-naïve patients with rheumatoid arthritis for 78 wks. Result: @26wks. patients achieved ACR20 (68.7% vs 72.7%) with a treatment difference of −3.98%, ACR20, 50, and 70 rates were similar with both groups The approval […]Read More

Regulatory

AbbVie’s Rinvoq (Upadacitinib) Receives CHMP Positive Opinion to Treat Moderate

Shots: The CHMP positive opinion is based on P-III SELECT program including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY assessing Rinvoq in 4,400+ patients with mod. to sev. active RA In P-III studies, Rinvoq improved signs and symptoms of RA, inhibited radiographic progression and improved physical function, both as a monothx. and in combination with conventional […]Read More