The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s (AZ) Forxiga (dapagliflozin) for the treatment of adults with chronic kidney disease (CKD).

This decision will give eligible patients diagnosed with CKD access to the first treatment pathway in nearly 20 years.

NICE’s most recent decision follows its draft recommendation – issued in November 2021 – which removed the urine albumin-to-creatinine ratio (uACR) testing restriction in the type 2 diabetes population, allowing increased access for patients in need of treatment.

CKD is a long-term condition where the patient’s kidney function is severely reduced, affecting the kidney’s ability to remove waste products from the body. The condition is a considerable burden on the UK healthcare system, representing 1.3% of NHS spending in total.

NICE’s recommendation was based on the DAPA-CKD phase 3 trial that demonstrated that dapagliflozin, in addition to standard of care, proved to be more effective than placebo plus standard of care in adult patients with or without type 2 diabetes.

These statistics are significant to minority ethnic groups including Black and Asian communities because these groups are fives times more susceptible to developing CKD than other groups, and are also less likely to access certain treatments.

In a study headed by Queen Mary University of London and Barts Health NHS Trust, Merck & Co’s – known as MSD outside the US and Canada – immunotherapy drug Keytruda (pembrolizumab) has been shown to significantly reduce the chance of breast cancer coming back, if administered at the right time and used in combination with chemotherapy.

The risk of the disease reoccurring was 37% lower in patients treated with Keytruda and chemotherapy, compared to those only treated with chemotherapy, after a follow-up period of more than three years.

After surgery, patients continued to receive either Keytruda without chemotherapy, or placebo.

Women diagnosed with cases of early triple-negative breast cancer where the disease had not progressed beyond the breast and lymph nodes – markers in stage 2 and 3 – were treated with Keytruda, which supplemented standard chemotherapy prior to surgery, with a follow-up treatment using Keytruda after surgery.

The Keynote-522 trial has been published in The New England Journal of Medicine and involved 1,174 patients in 21 countries with previously untreated stage 2 or 3 triple-negative breast cancer.

Keytruda is already used for a number of different types of cancer and works by helping the immune system destroy cancer cells.

The European Commission (EC) has granted marketing authorisation for Global Blood Therapeutics’ Oxbryta (voxelotor). The drug can be used to treat haemolytic anaemia caused by sickle cell disease (SCD) in patients 12 years and older.

The treatment will be the first sickle haemoglobin polymerisation inhibitor to be approved in Europe and can be used as monotherapy or combined with hydroxycarbamide (hydroxyurea). As a once-daily, oral treatment, Oxbryta works by increasing haemoglobin levels and reducing sickling and haemolysis.

The EC’s approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in December 2021 based on results of the phase 3 HOPE study.

The results, which were published in The New England Journal of Medicine in June 2021, showed statistically significant improvements in haemoglobin levels, accompanied by haemolysis for patients treated with Oxbryta. The analysis of the complete data from the HOPE study was published in The Lancet Haematology in April 2021.

Global Blood Therapeutics has submitted an application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorisation of the drug using the EC Decision Reliance Procedure.

Janssen – a branch of Johnson & Johnson – has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of teclistamab, a drug used to treat patients with relapsed or refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer affecting plasma cells – a type of white blood cell – found in bone marrow. If plasma cells become damaged, they can transform and grow in an abnormal way. The production of abnormal cells can result in an overcrowding in the bone marrow, suppressing the growth of healthy cells.

The majority of multiple myeloma patients are diagnosed with symptoms such as bone fracture or pain, low red blood cell counts, fatigue, high calcium levels or kidney failure. However, some patients living with the condition may initially experience no symptoms.

Janssen’s submission to the EMA is supported by evidence from the MajesTEC-1 trial – an open-label, multicentre clinical trial assessing the safety and effectiveness of teclistamab in adults with relapsed or refractory multiple myeloma.

Janssen’s application to the EMA follows a Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) for the approval of teclistamab for the treatment of relapsed or refractory multiple myeloma.

The US FDA has approved Sanofi’s Enjaymo (sutimlimab-jome) to treat adults with cold agglutinin disease (CAD), a rare blood disorder.

Bill Sibold, Sanofi’s executive vice president and head of Specialty Care, said: “Until now, people living with cold agglutinin disease haven’t had an approved treatment option to manage the constant destruction of red blood cells.”

This is the first treatment to be approved for patients with CAD and its approval was based on positive results from the pivotal phase 3 CARDINAL study.

CAD is a rare form of autoimmune haemolytic anaemia and is caused by cold agglutinins (antibodies) attaching to the surface of red blood cells. This begins a process which causes the body’s immune system to attack healthy red blood cells, leading to cell destruction known as haemolysis.

Enjaymo prevents the destruction of healthy red blood cells and therefore significantly reduces the need for patients with CAD to have red blood cell transfusions.

Patients with CAD are likely to suffer from severe anaemia, leading to fatigue, shortness of breath, light-headedness and chest pains, among other symptoms, due to the blood cells’ inability to carry oxygen around the body. It is estimated that CAD affects the lives of around 5,000 people in the US.