January/February 2022 • PharmaTimes Magazine • 8-9

// HOT OR NOT //


HOT & NOT

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending Rinvoq (upadacitinib) 15mg as a new option for treating adults with active psoriatic arthritis (PsA). This treatment is recommended for patients who have peripheral arthritis with three or more tender joints, and three or more swollen ligaments. PsA is an inflammatory disease, affecting an estimated 24 in every 10,000 people.


Saphnelo (anifrolumab), a first-in-class type 1 interferon receptor antibody, has been recommended for marketing authorisation in the EU. The drug has been recommended as an add-on therapy for the treatment of adult patients with moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE) alongside standard therapy. The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from the Saphnelo clinical development programme.


Bayer announced the positive Committee for Medicinal Products for Human Use (CHMP) opinion of finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes. The positive CHMP opinion is based on the results of the pivotal phase 3 FIDELIO-DKD study, investigating the effectiveness and safety of finerenone on kidney and cardiovascular outcomes in patients with CKD.


Bristol Myers Squibb (BMS) announced the Scottish Medicines Consortium (SMC) has accepted nivolumab plus ipilmumab as a treatment option for adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSIH) advanced colorectal (bowel) cancer. The therapy is for use by NHS Scotland after patients have previously failed fluoropyrimidine-based chemotherapy. The decision marks the first immunotherapy combination approved in Scotland for this patient group.


The number of cancer patients entering clinical trials has fallen during the pandemic, creating a barrier in accessing treatment options and delaying the development of innovative drugs, according to Hospital Pharmacy Europe. The National Institute for Health Research reported that the number of patients recruited onto clinical trials for cancer in England fell to 27,734 in 2020/21, down from an average of 67,057 over the previous three years.


Scientists led by a team from Arizona State University and Cardiff University believe they may have found the cause of the extremely rare blood clot complications stemming from the Oxford AstraZeneca COVID-19 vaccine. According to the study, the reaction can be caused by the adenovirus used by the vaccine to shuttle the coronavirus’s genetic material into cells, binding with a specific protein in the blood.