Pharmaceutical Market Europe • June 2026 • 9

NEWS

Genmab’s Tivdak recommended by NICE for cervical cancer

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Genmab UK’s Tivdak (tisotumab vedotin) has been recommended by the National Institute for Health and Care Excellence (NICE) for adults with recurrent or metastatic cervical cancer.

Tivdak is an antibody-drug conjugate (ADC) that can be used to treat adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. Interim funding via the Cancer Drugs Fund (CDF) will give eligible patients immediate access to the treatment.

Cervical cancer is the fourth leading cause of cancer-related deaths globally among women. It is estimated that 3,300 women are diagnosed with cervical cancer each year in the UK, resulting in approximately 900 deaths.

The disease recurs in up to 30% of cases among patients who have improved with initial treatment.

The recommendation is based on results from the global, randomised, phase 3 innovaTV 301 study that evaluated the efficacy and safety of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who were previously treated with chemotherapy doublet as well as bevacizumab and an anti–PD-1 or anti–PD-L1 agent if eligible and available.


AstraZeneca’s Baxfendy approved by US FDA for hypertension

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AstraZeneca’s Baxfendy (baxdrostat) has been approved by the US FDA to treat hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

Baxfendy is designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone, a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems.

The approval was based on positive results from the BaxHTN phase 3 trial, with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. Baxfendy was generally well-tolerated with no unanticipated safety findings.

There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure, which is a leading risk factor for cardiovascular disease and premature death. Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.


Novo Nordisk’s Wegovy approved as UK first daily GLP-1 weight loss pill

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A new daily weight management pill has been approved in the UK for adults to be used along with a reduced calorie diet and increased physical activity, offering a first-of-its-kind alternative to injectable treatments.

Novo Nordisk’s Wegovy pill (semaglutide tablets), an oral glucagon-like peptide-1 (GLP-1) receptor agonist licensed for weight management in adults living with obesity or overweight with at least one weight-related condition, has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA approval is based on data from the OASIS 4 phase 3 clinical trial. When evaluating the effect of treatment regardless of adherence, adults with obesity receiving semaglutide tablets 25mg achieved 13.6% weight loss vs 2.4% with placebo after 64 weeks, in addition to lifestyle modifications. Results showed that if all participants adhered to treatment, semaglutide 25mg achieved weight loss of 16.6% vs 2.7% placebo after 64 weeks.

The study evaluated semaglutide tablets 25mg in 307 adults with obesity, or overweight with at least one weight-related condition, without diabetes. The side effects were generally mild-to-moderate and transient


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